Title: Senior Specialist, Quality Assurance

Location: Iron Station, NC area

Schedule: M-F Full Time

Type: Direct Hire

Responsibilities:

Responsible for obtaining technical documentation from suppliers and administering the Supplier Audit database.

• The role will coordinate quality agreements, audits and risk assessments for API/Excipient manufacturers, contract laboratories, packaging suppliers and 3rd party contract manufacturers. This position will also provide assistance with review and approval of documentation from 3rd party contract manufacturers (batch records, deviations, CAPAs, process validations, etc.) and assist the Director in monitoring and providing quality metrics to senior management.

• Responsible for reviewing technical documents for 3rd party contract manufacturers. Technical documents include batch records, deviations/CAPAs, process validations, specifications, etc.

• Administers the Supplier Audit database and associated documents. Assists with performing supplier audits, risk assessments and maintaining audit schedules.

• Administers the CAPA system focusing on PA approval, closure and database tracking.

• Work with all levels of management to resolve issues discovered during review and participate in the problem-solving process.

• Partner with Supply Chain, R&D and Quality to obtain required supplier documentation to support qualification and risk assessment.

• Researches and prepares data needed for monthly quality metrics reporting to senior management.

• Other duties as assigned by management

  Requirements:

• BS degree in analytical field of study.

• Five plus years relevant experience in a pharmaceutical/industrial experience

• Strong technical writing and documentation review skills.

• Strong interpersonal and team building skills.

• Familiarity with current regulatory trends and knowledge of current cGMP's

• Good organization, documentation and communication skills

• Strong working knowledge of PCs and Microsoft applications.

• Experience with Trackwise preferred

System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.