Quality Assurance Specialist - Production Support
Company: Tergus Pharma
Location: Durham
Posted on: June 26, 2022
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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
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