Quality Assurance Specialist II/III
Company: Tergus Pharma
Posted on: November 11, 2019
Job Purpose: This position contributes 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:
- Review and approval of analytical documentation including
methods, validation protocols, analytical data and reports
(release, stability and validation).
- HPLC data review in Waters Empower 3
- Maintain and support completion of, including but not limited
to, SOPs, Specifications, MBRs, LIRs, OOS, Deviation, CAPA,
Complaints, Change Control, Equipment Qualification/Validation,
Methods and Protocols
- Track and trend quality system metrics such as LIR/OOS, DEV,
CAPA, Change Control and Customer Complaints.
- Perform CAPA review, approval and effectiveness checks.
- Support the vendor qualification program (documentation,
- Perform facility and quality system audits.
- 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
- 2+ years of analytical laboratory experience and/or process
- Experienced using Waters Empower 3 software.
- 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 with minimal
- 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 root cause
of a problem and working with others to correct problems
- Works toward common goals by supporting, encouraging and
sharing information with colleagues
- Speaks, writes, listens and presents information in a logical
and articulate manner
Keywords: Tergus Pharma, Raleigh , Quality Assurance Specialist II/III, Other , Raleigh, North Carolina
Didn't find what you're looking for? Search again!