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:
III. Position Requirements: Education or Equivalent:
- Primary quality liaison for clients and internal customers
- Subject Matter Expert for the client products, processes and requirements.
- Approval of Product Quality related customer complaint investigations
- Approval of Events, Deviations, CAPAs (manufacturing)
- Author Annual Product Review (APR) documents and trend reports
- 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 backroom.
- Other duties as assigned.
(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 thinking.
- Proficient in technical investigations, batch record review and technical writing
- 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
Apex 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