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Ampcus Inc. is a certified global provider of a broad range of Technology and Business consulting services. We are in search of a highly motivated candidate to join our talented Team.
Job Title: Quality Assurance Specialist
Location(s): Frederick, MD
Performs selected quality assurance activities, dependent upon assigned area, including the following:
- Reads, understands, and follows SOP's and complies with cGMP's
- Writes new standard operating procedures or revises existing documentation utilizing document management systems.
- Supports the evaluation and disposition of labelling, raw materials, intermediates and finished products through timely evaluation of batch records, laboratory results and other cGMP documents.
- Supports the issuance and reconciliation of GMP documentation.
- Electronic system usage with tools such as Trackwise/Veeva, GQCLIMS, Client-X and SAP.
- Understands basic scientific principles and cGMP.
- Basic knowledge of functional procedures and routine activities within core area.
- Applies knowledge to recurring, standardized tasks.
- Uses basic analytical skills to develop solutions to task-related problems.
- Escalates/seeks support for more complex problems as appropriate.
- Works under regular and routine supervision following standard procedures.
- Receives detailed instructions for new assignments.
- Priorities are set by others.
- Work is reviewed for accuracy and completeness.
- Contributes to department goals through quality and efficiency of standard work.
- Contacts are primarily with department peers and supervisor and cross-functionally with peers/supervisors from other internal departments. Rarely any external contacts.
Years of experience:
- Education: Minimum of Associate degree (or equivalent) in science-related field.
- 0-3 years experience in biopharmaceutical/pharmaceutical industry.
- Bachelors degree or 4 additional years of work experience in lieu of degree.
- AA or 2 additional years of work experience in lieu of a degree.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veterans or individuals with disabilities.
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Ampcus, Inc
Jul 03, 2025