QA Specialist
Company: PharmEng Technology Americas
Location: Holly Springs
Posted on: February 24, 2026
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Job Description:
Job Description Job Description QA Specialist PharmEng
Technology has been providing quality services to leading
manufacturers of healthcare and pharmaceutical products since 1997.
Our specialists hold expertise in Commissioning & Qualification,
Validation, Quality Systems, Regulatory Affairs, Engineering, and
Training to ensure that our clients can keep on providing the world
with their cost-effective and high-standard healthcare products. At
PharmEng Technology, we strive to cultivate the best working
environment where empowerment, passion and perseverance are
nurtured while serving our clients to achieve their unique business
goals. Responsibilities Function as primary FLQA and Quality
Management System (QMS) subject matter expert to assigned area(s)
of responsibility within Bulk Manufacturing, QC laboratories, Fill
Finish Manufacturing, Facilities, and Warehouse operations. Perform
quality oversight and approval of Deviations, CAPAs, and Change
Controls in collaboration with Record Owners. Ensure
investigations, cause identification, CAPA development, and
accurate change controls within Bulk, QC, Fill Finish, FacOps, and
Warehouse departments. Track closure of assigned QMS records.
Participate in suite team meetings, provide FLQA support for
projects and initiatives. Conduct on-the-floor walkthroughs and
coaching to instill a quality mindset, compliance knowledge, and a
strong quality culture among manufacturing staff. Bring adherence
to and continuous improvement of quality systems within Bulk, QC,
Fill Finish, FacOps, and Warehouse departments. Support
development, revision, and implementation of SOPs, protocols, and
other GMP documents. Help deliver Deviation, CAPA, and Change
Control Annual Product Quality Review (APQR) sub-reports. Lead
continuous improvement projects, offer quality support to site
capital projects and global quality system improvements. Ensure
inspection readiness through routine quality walkthroughs,
monitoring adherence, and direct involvement in Site Self
Inspections. Be a QA SME for internal and external audits.
Proficiently use computerized systems including TrackWise, Veeva
QMS and QDocs, GLIMS, SAP, CMMS. Provide support to greater FLQA
organization, including quality oversight of Bulk Manufacturing/QC
Laboratories and QA reviews of batch records and GMP records at the
site. Acquire and maintain knowledge of current local and
international regulatory requirements/trends, ensuring advice and
technical support on quality/compliance matters are provided to the
site. Requirements Bachelor's degree in a relevant scientific
discipline (Pharmacy, Chemistry, Biology, Biochemistry) preferred
or equivalent experience in biotech or pharmaceutical industry 3
years' GMP experience in the pharmaceutical/biotech industry
Previous experience directly working in the industry or having
direct responsibilities approving GMP deviations, CAPAs, and change
controls. Previous experience in root cause analysis and risk
management, including working experience of root cause analysis
tools such as Fishbone/5Why Previous experience in quality role in
an FDA regulated manufacturing or laboratory setting or an
understanding of the quality requirements for the pharmaceutical
industry. Experience with the production processes used in
pharmaceutical parenteral drug product manufacturing.
Keywords: PharmEng Technology Americas, Durham , QA Specialist, Science, Research & Development , Holly Springs, North Carolina
