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

TECHNICAL WRITER III

Bachelor’s Degree in Engineering – Chemical, Mechanical, Biomedical or others. MUST HAVE BIOTECH/ PHARMACEUTICAL/ MEDICAL DEVICE industry experience. Work on the technical documents so understanding the engineering side of it would be a huge plus. Experience working with change control GMP Applications such as Track wise Experience in electronic Document Management System such as Documentum. Experience in Visio to work on CAD drawings, a huge plus. Experience with facilities / utilities technical writing would be huge plus. Experience writing SOPs – Standard Operating Procedures. Minimum of bachelor’s degree; Preferred Chemical or Mechanical Engineering Degree Technical writing experience including manufacturing procedures and instructions Demonstrates knowledge of current Good Manufacturing Practice (FDA, EU and ICH) requirements and Quality Systems, with the ability to assess compliance risks. Demonstrates analytical problem-solving skills. Demonstrates ability to explain complex concepts with clarity and simplicity. Demonstrates ability to perform detail-oriented work with a high degree of accuracy. Demonstrates strong verbal, written, and interpersonal communication skills. Demonstrates proficiency in Microsoft Office applications and Adobe Acrobat Professional.

Primarily, writes, edits, and reviews cGMP facilities/ utilities documents, Change Controls, SOPs, and engineering/IT related material in support of Computers, Automation and/or Manufacturing activities while maintaining standardized and consistent documentation practices for recording details of new processes. Maintains standardized language and documentation practices that allow for consistent execution of documents. Edits documents written by others to verify accuracy, consistency, grammar, and format. Interacts closely with Project Management, Manufacturing, and QA.

Document Control Clerk

Qualified candidates must have experience in the pharmaceutical industry.

Must have 5 plus years of hands on experience performing Document Control.

Minimum education Associate’s Degree.

Project Manager – 28613

Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

Supply Chain Management, Software Trackwise QMTS, Excel Intermediate/Advanced, Product Launches and Post Launch Variations.

Description:

SUMMARY
Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

FUNCTIONS
1. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
2. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
3. Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
4. Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
5. Maintain and track project budget(s).
6. Reconcile the use of resources for the projects.
7. Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
8. Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
9. Actively participate in directing the evolution and defining the role of the project
10. Ensure the project goals and objects are well understood by the various functional areas.
11. Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
12. Maintain the master project plan and schedule for assigned projects.
13. Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
14. Provide department management with project management support on an as needed basis as well as for special projects.
15. May manage and direct the activities of project support staff
16. Conduct annual performance reviews and provides career counseling and general guidance.
17. Identify or lead focus area projects within the overall function of project management or related projects.
18. Generate periodic updates and prepare formal presentations for required forums.
19. Generate individual and more complex reports utilizing various resources.
20. Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
21. Ensure project work complies with practices, policies and standard operating procedures.
22. Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
23. Anticipate resource needs and communicate to management sponsors.

• Other functions that may be assigned.

EDUCATION
Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

PREFERRED QUALIFICATIONS
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure, and effectively in a team matrix environment.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment.
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).
• Ability to assume increasing levels of responsibility.

Specialist QA – 28592

Doctorate degree in Sciences/Engineering or master’s degree in Sciences/Engineering & 3 years of directly related experience or bachelor’s degree & 5 years of directly related experience.

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 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.

Licensed Electrician – Manatí, PR

We are looking for available resources to be considered for a project that starts immediately.

Qualified candidates must have experience in the pharmaceutical industry. Must have excellent English skills (reading, writing and speaking). For a third shift.

Qualified resources, send an updated resume in Microsoft Word.

Validation Support Specialist – Syracuse, NY

We are seeking available resources to be considered (w-2 temporary employment status) for a project starting approximately at the end of April 2019 until the end of August 2019 as per client need.

There is sizable work to be done that is proposed including IQ/OQ of new dispensary down flow booths, airflow visualization studies, IQ/OQ/PQs for the warehouse, and a fume hood IQ/OQ.

Our customer will need dedicated people that will be available and knowledgeable specifically for these activities.

Qualified candidates must have an Engineering bachelor’s degree and 5 plus hands on experience in the pharmaceutical Industry. Must have excellent English skills (read, write & speak).

C&Q Specialist – Exempt – Arecibo

The role is responsible to support and lead all aspect of the Commissioning and Qualification (C&Q) program Life Cycle from design through operation and maintenance.  The role will develop and manage the commissioning and qualification program of the site.  The resource will assure the compliance with cGMP, GAMP and ISPE guidelines.  The role is responsible to prepare site validation documentation such as User requirements, design and functional specifications, qualification protocols, master plans, risk assessments, periodic reviews, among others.  The resource will coordinate the work of contractors for multiple projects and will assure the projects are well documented in the site change control system.  The resource could support for a limited time other functions such as project management and technical evaluations for the site.

A bachelor’s degree in Science such as Pharmacy, Engineering, Biotechnology, Chemistry, Physics or Biology.  Minimum of 5 years of experience in a highly-regulated industry like Pharmaceuticals and/or Medical Devices.   Knowledge in cGMP, GAMP, ISPE and computerized system life cycle guidelines.  Knowledge on site utilities (HVAC, Compressed air, Purified water, etc.) and facility is required.

The role will develop and manage the site Commissioning and Qualification Program of the site and will assure compliance with cGMP, GAMP and ISPE guidelines. It will provide alignment and compliance with international guidelines/standards support site flexibility and a faster implementation of projects and new product introduction.

Ayudante de Refrigeración – Hatillo

Empleado/Empleado temporero.

Estudios en área de refrigeración.

Licencia de conducir.

No requiere de experiencia.

Commissioning Specialist ( Las Piedras, PR Short Term Project)

  • We are seeking a contractor with experience performing Commissioning for Fire Alarm systems.
  • Must have experience performing similar projects in the pharmaceutical industry
  • Project expected to start by the end of March 2019 and end by April 2019
  • Contractions must have immediate availability to be considered
  • Qualified/Available contractors – please submit resume to: careers@dmcginc.com