Quality Assurance Specialist - Production Support

Company: Tergus Pharma
Location: Durham
Posted on: June 26, 2022

Job Description:

Job Purpose: The 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 facility. Summary of Key Responsibilities: --- Quality Assurance on-the-floor support for GMP/GLP manufacturing activities. --- Quality Assurance review and approval of manufacturing documentation, including specifications and release, batch records, and batch release. --- Quality Assurance review and approval of instrument/equipment calibration documentation, investigations, deviations, CAPAs and change controls. --- 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. --- Track and trend LIR/OOS, DEV, CAPA, Change Control and Customer Complaints. --- Perform CAPA review, approval and effectiveness checks. --- Support the vendor qualification program (documentation, audits, etc.). --- Perform facility and quality system audits. --- 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, production environment.One or both of the following: --- 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). --- 5+ years of analytical laboratory experience wet chemistry monograph testing, DP testing (USP, EP, JP), LIMs, ELN, Method Validation, Specification generation.Additional: --- 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 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. --- Possess computer application skills in the MS Office Suite.Tergus Pharma is an Equal Opportunity Employer. M/F/Vet/Age/Race/Religion/Disability/National Origin/Sexual Orientation/Gender Identity.

Keywords: Tergus Pharma, Durham , Quality Assurance Specialist - Production Support, Professions , Durham, North Carolina