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: email@example.com
Doctorate degree in Sciences or Master’s degree in Sciences & 3 years of experience directly related to the job or Bachelor’s degree in Sciences & 5 years of experience directly related to the job. Previous experience managing complaints and investigations.
Primary responsibilities include: Supporting the product complaint system at Client through; leading and managing product complaint investigations, performing data analysis and trending of complaint information to proactively detect signals and take appropriate actions in a timely manner. Functions: Keep the complaints database updated as soon as information is available and summarize closed investigations into the database accurately. Ensure complaint related investigations are concise, clear and science-based by reviewing and approving such investigations.
Follow-up on corrective actions derived from investigations through completion. On occasion, depending on the nature and complexity of the complaint, the specialist may be responsible of conducting and documenting the investigation. Therefore, the candidate must possess excellent writing skills that include closing the gap between a highly technical investigation into a simple and concise document that can be understood by non-technical reviewers.
May also include: Communication and escalation of complaints, site representation on the product complaint network and generation and issuance of closure letters to patients and business partners.
Education/Licenses: Doctorate degree or Master’s degree & 3 years of experience directly related to the job or Bachelor’s degree & 5 years of experience directly related to the job
Strong project management skills, experience leading cross-functional teams, and the ability to handle multiple projects simultaneously is a must. Excellent written and verbal communication skills, including facilitation and presentation skills. Able to work in a team-oriented, matrix environment and work effectively with diverse departmental groups Be self-motivated, able to interface effectively with various levels, attentive to details and able to prioritize and meet deadlines, and must possess excellent leadership, problem solving, analytical, influencing and customer service skills to operate and deliver results in a matrix-managed GMP environment. Computer literacy, independently understand, follow and implement instructions, work independently or as a team player and collaborate with outside resources, and the ability to evaluate issues, make decisions and determine when to escalate, as necessary.
Doctorate degree in Sciences/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 8 years of directly related experience.
Experience: Validation, Investigations, SOP, Regulatory, Lean Knowledge.
• In support of Client’s Quality Assurance program acts as the technical specialist. Review and approve product MP’s.
• Approve process validation protocols and reports for mfg. Processes. Represent Quality on incident triage team.
• Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents.
• Represent QA on NPI team. Lead investigations. Own site quality program procedures.
• Designee for QA manager on local CCRB.
Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 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 processes development. Demonstrated 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.
Bachelor’s Degree in: Chemical Engineering or Life Sciences (Chemistry, Biology).
Previous experience in process validation is required.
Even when Administrative hours is the main shift, however, job seeker must be available to work non-standard shifts during execution of process characterization/validation activities.
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 teamwork.
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).
Las Piedras, PR
Openings – 2
Employment Status – temporary employee nonexempt
CMMS Data Transformation Project Specialist:
• Raises, executes, and reviews Computerized Maintenance Management System (CMMS) records change requests in support of a data transformation project conductive to optimization of the maintenance system and a migration from Maximo 7.x to SAP PM.
• Assess and addresses CMMS master records gaps with regards to a new standard.
• Creates business processes and develops workflow specifications to meet end requirements.
• Supports the CMMS system migration to maintain the accuracy of any records of the CMMS system to satisfy the business needs while maintaining a strong compliance posture.
• Bachelor’s Degree in Science, Engineering or related discipline.
• 4 to 6 years of relevant experience.
QUALIFICATIONS Specific Knowledge, Skills, Abilities, etc.:
• Strong knowledge of CMMS Technology (e.g., Maximo 7.X, SAP PM), Quality Systems and other computer software / databases as it relates to performing duties of this position.
• Moderate knowledge of Structured Query Language (SQL).
• Proficient in Excel and Access related tools is preferable.
• Strong knowledge in asset management is highly desirable.
• Understanding of facilities and building maintenance activities and functions including utilities infrastructures.
• Experience working in an outsourced facility maintenance environment is a plus.
• Understanding of regulatory, environmental, GMP/GLP and OSHA regulations.
• Understanding of process equipment.
• Being able to interpret engineering drawings and other technical documentation.
• Excellent organizational skills and sense of urgency.
• Develop assets hierarchies, safety work instructions, maintenance work instruction, bill of materials, assets spare parts, preventive maintenance schedules, etc.
• Follow guidelines, nomenclature and change control within the CMMS, preventive maintenance and validation program in order to ensure data integrity and maintain accuracy of the information that resides on the CMMS system.
• Work within a team environment with other Facilities & Engineering functions, including Facilities, Reliability, and Engineering.
• Support the data transformation project and subsequent data migration development and modification of associated project documents (i.e. change controls, SOPs, validations packages).