-
ID
#12269395 -
Job type
Permanent -
Salary
TBD -
Source
Apex Systems -
Date
2021-04-14 -
Deadline
2021-06-13
Quality Assurance Specialist (Pharmaceutical)
Maryland, Rockville, 20847 Rockville USAPermanent
Vacancy expired!
We are searching for a Quality Assurance Specialist to join a growing pharmaceutical company in Rockville, MD!
Title: Quality Assurance Specialist Location: Rockville, MD (some remote work) Salary: $70,000-$95,000/year plus benefits Type: Direct-Hire opportunity Overview :Ensure all aspects of QA to meet compliance regulations related to documents received from contract manufacturers. In addition, interface with contract manufacturers when review and approval of manufacturing documents are required. Responsibilities:- Perform batch record review and lot disposition of CMOs
- Interface with CMOs in reviewing and processing documentation for approval and release of product (analytical data, specifications, labeling, batch records, etc.).
- Ensure that standards and safety regulations are observed at the CMOs.
- Manage the External Document Review (EDR) process by routing the review and approval of external documents received from CMOs.
- Review and approve Certificates of Analysis (CofA) and Certification of Conformance (CoC).
- Provide assistance to Document Control, when needed.
- Bachelor's or Master's degree in Life Science related field
- 5-10 years within Quality Assurance for an industrial pharmaceutical company
- Experience reviewing and analyzing documentation including but not limited to:
- Batch records
- CAPA's
- Deviations
- Change Controls
- Label Specifications
- Stability testing
- Understanding of analytical data sets from HPLC and microbiology testing
Vacancy expired!
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