Quality Analyst 1 - On-site in Frederick, MD
Must be able to work on a W2
Performs selected quality assurance activities, dependent upon the assigned area, including the following :
- Reads, understands and follows SOPs and complies with cGMPs
- Writes new standard operating procedures or revises existing documentation utilizing document management systems.
- Supports the evaluation and disposition of labeling, 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, GQCLIMS, Pas-X, and SAP.
- 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.
Qualifications
- 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.
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
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