Quality Assurance Specialist II/III (Lab Focus)
Company: Tergus Pharma
Posted on: January 16, 2022
The Senior QA Specialist will contribute to the Company's
success by ensuring compliance with GMP/GLP regulations and
internal procedures within a GMP/GLP analytical and manufacturing
Summary of Key Responsibilities:
- Track and trend LIR/OOS, DEV, CAPA, Change Control and Customer
- Perform CAPA review, approval and effectiveness checks.
- Reviewing and approving analytical test method validations with
respect to compendia and drug product intended use.
- Stability indicating analysis trending and APR reporting.
- Support the vendor qualification program (documentation,
- Maintain / archive all documentation, including but not limited
to, SOPs, Specifications, MBRs, LIRs, OOS, Deviation, CAPA,
Complaints, Change Control, Equipment Qualification/Validation,
Methods and Protocols.
- Perform facility and quality system audits.
- Review and approval of analytical documentation including
methods, validation protocols, analytical data and reports
(release, stability and validation).
- Quality Assurance review and approval of instrument/equipment
calibration documentation, investigations, deviations, CAPAs and
- Quality Assurance review and approval of manufacturing
documentation, including specifications and release, batch records,
and batch release.
- Other duties as assigned. Required Qualifications and Skills:
- B.A. or B.S. in a scientific discipline.
- 4 - 6 years' experience in a Quality Assurance/compliance role
in a GMP/GLP-compliant pharmaceutical, analytical environment.
- One or both of the following:
- 5+ years of analytical laboratory experience wet chemistry
monograph testing, DP testing (USP, EP, JP), Application:
Chromatographic Data Base CDS (Empower / Open Lab), LIMs, ELN,
Method Validation, Specification generation.
- Manufacturing process knowledge batch record execution
(MBR/EBR) equipment set-up, Technical Transfer, Process & Cleaning
Validation protocols, Supply Chain material management ERP systems
(SAP, Oracle, MS 365).
- Proven ability to review and evaluate the content of
documentation; conscientious about attention to detail; uses
logical thinking that is well organized and methodical.
- Proven ability to collaborate with technical staff across the
organization with minimal management oversight required.
- Able to multi-task productively, applying time management
processes and procedures effectively.
- Technically capable of determining what is wrong in complex
situations and offering potential solutions, identifying the root
cause of a problem and working with others to correct
- Works toward common goals by supporting, encouraging and
sharing information with colleagues.
- Speaks writes, listens, and presents information in a logical
and articulate manner.
- Possess computer application skills in the MS Office Suite.
Tergus Pharma is an Equal Opportunity Employer.
Keywords: Tergus Pharma, Durham , Quality Assurance Specialist II/III (Lab Focus), Healthcare , Durham, North Carolina
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