DMCG Careers

Want to join our team? Attach your resume, and we will contact you as soon as a position is available. DMCG is constantly working on new client needs. Here are some of the general client role descriptions that DMCG is currently looking to fill. If you are interested please send your MS Word (no PDF) format resume. One of our representatives will contact you as soon as possible.

Resumes to: careers@dmcginc.com

Electronic Technician

Barceloneta, PR

MORE DETAILS

Second shift (1)
Third shift (1)

We are seeking contractors with a Technical Degree as Electronic Technician.
Must have experience 2-5 years in the pharmaceutical industry, exposed to utilities, troubleshooting, SCADA, Calibrations among others.

Laboratory Computer Systems Validation – (26624)

Las Piedras, PR

MORE DETAILS

Bachelor’s degree in engineering, computer science or related field. 5 years’ Experience with validating Laboratory equipment such as IR and Titrators. Knowledge of OMNIC, TIAMO, CS suite, Qdoc or Data Pro Heavily preferred.

Responsibilities:
SME for Generation and execution of CSV protocols.

Specialist QA – (29000)

Juncos, PR

MORE DETAILS

Doctorate degree or Master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience / preferably in Science (Microbiology, Biology, Chemistry, Biotechnology), with at least 5 years of experience in the pharmaceutical or biotechnology industry.

Experience in electronic batch record review; experience with isolator technology; able to take decisions related to quality events; experience in visual inspection of filled product; willing to work non-standard shifts; able to gown in support to routinely work at controlled rooms; perform aseptic processing audits; perform quality oversights of facilities, process, and personnel; approve quality deviations; experience in regulatory audits; presentation skills, written skills to issue daily reports.

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.
COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

Specialist Quality Complaints – (28963)

Juncos, PR

MORE DETAILS

Administrative Shift

Seeking Contractors with the following experience/ expertise:

Doctorate degree in Sciences or Master’s degree in Sciences & 3 years of directly related experience or Bachelor’s degree in Sciences & 5 years of directly related experience

• BS in Chemistry or Biochemistry preferred
• Knowledge in TrackWise, CDOCS, Maximo
• Knowledge in PowerPoint, Excel, Word, One Note

Expertise in Technical Writing, must have written reports for investigations, method transfers/validations

• Root Cause Analysis experience and CAPA identification and implementation
• Fully bilingual English/Spanish
• Meeting and conference calls facilitator, with multilevel audience (Upper level Management to analysts)
• Presentation skills
• Oriented to solve problems and troubleshoot, technical proficiency
• Simple statistical assessments

General Project Role Description need:

Under general direction, functions as the technical specialist for testing & development in areas of molecular biology and microbiology. Focus is on the complex technical issues and scope is typically multi-organizational and/or multi-site and /or involving outside resources. Functions: Responsible for providing technical guidance, provide reports, data analysis and ensure flow of communication between technical groups including following up on and resolving issues that arise. Resolve technical issues and troubleshoot for assays as necessary, ensure lab compliance – which includes implementing procedures that enhance GMP, GLP and safety. Manage existing and/or develop and implement new programs, processes and methodologies, Develop, revise and audit various complex controlled documents that may have multi-organizational and/or multi-site impact. Approve lab investigations, Lead audit teams May serve as subject matter expert to develop technical training. May perform routine work in a specific area of responsibility as necessary. Represents the department/organization on various teams, independently responsible for following through on multi-site action items. May interact with regulatory agencies regarding area(s) of responsibility including written responses. May resolve issues with outside resources. Performs special projects as requested by supervisor, May supervise employees as necessary to meet technical requirements.

Education/Licenses: Doctorate degree or Master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience or Associate’s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.

Competencies/Skills: Understand, support and demonstrate the Client site values. Excellent communication skills, facilitation and presentation skills. Excellent technical writing skills. Strong computer operation skills including work processing, presentation, database and spreadsheet application skills, Excellent project management and organizational skills including the ability to independently understand, follow, implement complex instructions and follow assignments through to completion. Advanced skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. Excellent knowledge of and experience with processes involved in quality analytical labs, validation, manufacturing, quality assurance, process development and distribution.

Extensive knowledge of all testing including the development and validation of assays and the ability to perform all testing in specific area of responsibility. Knowledge of pharmaceutical processes, Strong knowledge of U.S. regulations and practices pertaining to the testing of pharmaceutical/biological products. Knowledge of basic international regulations and practices pertaining to the testing of pharmaceutical/biological products.

Extensive knowledge and application of GMPs/CFRs. Ability to evaluate compliance issues. Skill in evaluating and documenting according to Company and various guidelines. Proficient at maintenance, troubleshooting and operation of equipment in area of expertise. Advanced scientific data analysis and interpretation skills. Advanced skills in solving complex problems. Advanced data trending and evaluation. Strong skill in working independently and to effectively interact with various levels. Ability to interact with regulatory agencies both orally and in writing. Initiate, coordinate and lead cross functional teams. Excellent skill in leading, motivating, influencing, and negotiating.

Process Development Scientist (28943)

Juncos, PR

MORE DETAILS

Bachelor’s degree in Life Sciences or Engineering and 5 years of Scientific experience OR Master’s Degree in Life Sciences or Engineering and 3 years of Scientific experience.

PROFICIENT IN:
Project management
Statistical knowledge
Math modeling
Basic Programing knowledge

Description:

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills.

Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

Accounting Manager – (29003)

Juncos, PR

MORE DETAILS

Doctorate degree in Accounting or Master’s degree in Accounting & 3 years of directly related experience or Bachelor’s degree in Accounting & 5 years of directly related experience.

• Excellent computer skills including spreadsheet software.
• Excellent data analysis skills.
• Good financial business understanding.
• Strong organizational skills with ability to work in a cross-functional team environment.
• Ability to demonstrate judgment and make appropriate recommendations.
• Experience in driving and implementing change.
• Experience managing outsource partner relationship.
• Experience in financial system implementation.
• Experience in US GAAP and Foreign Currency transaction accounting and understanding concepts to translate into guidance for financial reporting.
• Experience in other functional accounting areas (i.e. cash, investments).
• Detail orientated; strong business analytical skills.
• Strong systems skills – inclusive of SAP.
• Strong written, verbal communication and presentation skills (English and Spanish).
• Positive attitude and a strong work ethic.
• Ability to multi-task, prioritize and manage multiple deliverables.
• Exceptional interpersonal skills; influence at all levels, functions and geographies.

Description:

Provide complex account analyses and journal entries and may supervise/manage and review accounting staff and analyst work. Functions: Prepare and review complex journal entries. Perform and review complex general ledger account analysis and reconciliation. Prepare and review audit schedules and answer complex questions from internal and external auditors. Preparation and review of complex financial schedules such as footnote, month-end flash reports, LE (latest estimate) support and other ad hoc schedules. May supervise/manage and review accounting control functions and reporting requirements such as: Corporate partner billings, Royalties, Dept. of Commerce filings, Sales & Use tax returns, responds to internal Client staff complex questions regarding accounting issues, Special projects may be assigned.

Education/Licenses: Doctorate degree or master’s degree & 3 years of directly related experience or Bachelor’s degree & 5 years of directly related experience or Associate’s degree & 10 years of directly related experience or High school diploma / GED & 12 years of directly related experience.

COMPETENCIES/SKILLS: Excellent computer skills including spreadsheet software, Excellent data analysis skills, Strong communication skills including written and verbal, Basic presentation skills, Good financial business understanding, Strong organizational skills, Strong understanding and application of basic accounting principles including GAAP (Generally Accepted Accounting Principles), Ability to demonstrate judgment and make appropriate recommendations, Develop and maintain operational processes and procedures, Ability to work effectively with senior management.

 

Supply Chain Manager – (28969)

Juncos, PR

MORE DETAILS

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

Preferable with experience in Technical Writing and Investigations.

Description:

Under minimal supervision provides Supply Chain work group supervision and technical expertise in support of successfully completing daily operations within scope of responsibility. Ensures all work is completed with minimal disruption and in compliance with all cGMP guidelines and Client procedures. Direct and coordinate daily activities of personnel responsible for material receipt, storage and transport. Ensures materials are received, stored and transported according to established performance standards and all applicable procedures and regulations. Interacts with internal and external regulatory agencies to ensure compliance with cGMP, DOT, OSHA requirements. collaborate with other sites to maintain optimal flexibility for the storage of all materials and product. Identify and oversee implementation of new and improved business and compliance systems and tools. Partner with key internal customer groups and/or external suppliers to ensure successful operations and performance targets are achieved.
Responsible for business continuity programs for assigned areas. Participate on global functional teams to coordinate and improve the transportation and Logistics of material movement and storage across the Client Supply Chain.
Direct and coordinate daily activities of personnel responsible for developing and managing Product demand and forecasts. Organize and communicate on a regular basis the total demand and supply requirements to senior management. Coordinate the Master Production Schedule for Finished Goods and effectively communicate any impact created by, and to the supply plan. Manage the process of gathering, evaluating and feedback of global demand requirements. Provide and coordinate the development of business case scenarios that demonstrate the impact of current or proposed operations plans. Manage the preparation and communication of the Company wide Inventory Distribution Plan to achieve corporate goals of customer satisfaction and risk management.
Develop and coordinate the long-range production requirements based on Marketing forecasts, product approval and release timelines, clinical requirements, SKU put-up information and business planning timelines estimates.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS
Must have well developed skills from Supervisor I level in addition to the following: Facilitation and presentation skills, Strong analytical problem solving skills, Strong technical writing skills, Strong project management skills, Change management skills, Ability to influence staff and effect change outside of area of responsibility, Initiate and lead cross-functional teams to resolve complex issues, Good decision making skills, Technical expert for function, Possess an understanding and appreciation of the Client Values and Leadership Attributes, While performing the duties of this job, the environment for the staff member is of an office atmosphere. Computer terminals, telephones, and calculators are in use constantly. Assignments are received in task and objective oriented terms. Provides direction to subordinates using established policies and procedures. Work is reviewed upon completion for adequacy in meeting the task / objective. Administers policies and procedures that typically affect individual staff members within one or more functional work groups. Accomplishes tasks mainly through general supervision of nonexempt and experienced exempt employees. Monitors daily operations of a work group and actively assists, or provides direction to, subordinates as required. May perform ongoing operational tasks. Makes decisions regarding group operations. Erroneous decisions or recommendations or failure to achieve results might cause delays in program schedules and result in the allocation of more resources. Ensures tasks and projects are efficiently completed on schedule following established procedures and within budget. Majority of liaison is on internal basis with subordinates and supervisors at equivalent level or one level higher. Regularly conducts briefings to management. Liaison normally involves specific phases of a project or operation. External contacts are regular and generally involve coordinating operational issues.

Specialist QA – (28945)

Juncos, PR

MORE DETAILS

Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s in Sciences/Engineering degree and 5 years of directly related experience.
Experience auditing manufacturing processes and / or documentation, preferably in sterile / parenteral operations. Read and write in English is a must.
Availability for 2nd and 3rd Shift.

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.