Job Details

ID #12375534
State Maryland
City Rockville
Job type Permanent
Salary USD TBD TBD
Source Apex Systems
Showed 2021-04-18
Date 2021-04-17
Deadline 2021-06-16
Category Software/QA/DBA/etc
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Quality Assurance Specialist (Pharmaceutical)

Maryland, Rockville, 20847 Rockville USA

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.

Requirements:
  • 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

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or

Vacancy expired!

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