Product Quality Specialist
Company: Apex Systems
Posted on: February 21, 2021
Our client is looking for a Product Quality Specialist for their
office in Morrisville, NC. Candidates must have GMP, CAPA, and APR
experience to be considered. If interested, please send your resume
to Sarah at !Position Title: Product Quality SpecialistReports to:
QA ManagerI. Position Overview: The position is responsible for
coordinating overall operations of the Quality Assurance function
as related to specific assigned products and customers at the
Morrisville site.II. Essential Functions:
- Primary quality liaison for clients and internal customers
- Subject Matter Expert for the client products, processes and
- Approval of Product Quality related customer complaint
- Approval of Events, Deviations, CAPAs (manufacturing)
- Author Annual Product Review (APR) documents and trend
- Effectively coordinates functions of internal QA organization
with customers and necessary departments. Specifically: reviewing
and closure of investigations (major and minor deviations),
reviewing and closure of non-critical customer complaints,
reviewing executed batch records and support data, performing
trending of product specific data, review and approval of Master
Batch Records, and author applicable sections of the Annual Product
Review/Annual Quality Review.
- Responsible for supporting internal, client, and regulatory
audits through coordination and/or leadership of the audit
- Other duties as assigned. III. Position Requirements: Education
or Equivalent: (Minimum required to perform job) Bachelor of
science degree in related field
(Chemistry/Engineering/Pharmaceutical Science). Experience: 2-3
years of experience in the pharmaceutical industry in Quality
function Knowledge/Skills Requirements:
- High level of attention to detail.
- Proficient in problem solving, analytical skills and critical
- Proficient in technical investigations, batch record review and
- Ability to interpret a variety of instructions furnished in
written, oral, diagram, or schedule form.
- Review documentation for accuracy and completeness.
- Strong computer and appropriate communication skills (both
written and oral) allowing direct interaction with external clients
and RTP internal staff.
- Demonstrated ability to read, write, and speak clear English.
- Frequent sitting, walking, reading of written documents and use
of computer monitor screen, writing, talking, carrying, listening
- Performance driven
- Customer focused
- Collaborative and inclusive EEO EmployerApex Systems is an
equal opportunity employer. We do not discriminate or allow
discrimination on the basis of race, color, religion, creed, sex
(including pregnancy, childbirth, breastfeeding, or related medical
conditions), age, sexual orientation, gender identity, national
origin, ancestry, citizenship, genetic information, registered
domestic partner status, marital status, disability, status as a
crime victim, protected veteran status, political affiliation,
union membership, or any other characteristic protected by law.
Apex will consider qualified applicants with criminal histories in
a manner consistent with the requirements of applicable law. If you
have visited our website in search of information on employment
opportunities or to apply for a position, and you require an
accommodation in using our website for a search or application,
please contact our Employee Services Department at or - provided by
Keywords: Apex Systems, Cary , Product Quality Specialist, Other , Morrisville, North Carolina
Didn't find what you're looking for? Search again!