QA Compliance and Systems Specialist Job

QA COMPLIANCE AND SYSTEMS SPECIALIST needed for a CONTRACT opportunity with Yoh's client located in Holly Springs, NC.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

- Quality Assurance
- EU, FDA and cGMP regulations
- Investigations

WHAT YOU'LL BE DOING:

- Coordinate and facilitate assessments and follow-up activities of third parties such as suppliers of raw materials, drug products, container-closure systems, and packaging/labeling materials; external contract laboratories; GMP service providers; and contract manufacturing organizations.
- Write follow-up letters and other communications to suppliers.
- Issue, track and report follow-up status for supplier questionnaires, supplier quality audit responses and related CAPAs, and Quality Agreements.
- Work with external auditors to compile relevant supplier data packages and provide summaries for supplier approval.
- Attend internal supplier/material related meetings governing selection of new materials for the site and track/provide updates regarding the status of supplier/material approval.
- Assist with maintenance of the supplier audit schedule, supplier status tracking and approved supplier spreadsheets.
- Support supplier change notification review and approval.
- Prepare and/or revise and assist with implementation of relevant SOPs.
- Maintain supplier approval documentation and ensure the electronic audit information Management is kept up to date.
- Acts as Change control coordinator for all supplier and materials related change controls.
- Supports other Quality systems activities as needed.
- Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.

WHAT YOU NEED TO BRING TO THE TABLE:

- Bachelor's degree in the field of Science or Engineering or other appropriate field of study
- Minimum of 3 years in Quality Assurance and/or in a GMP regulated environment within the pharmaceutical industry, including supplier management experience.
- Strong knowledge of EU, FDA and cGMP regulations.
- Experience in conducting investigations is required.
- Excellent interpersonal effectiveness and written and verbal communication skills.

BONUS POINTS! OTHERWISE KNOWN AS PREFERRED QUALIFICATIONS:

- Supplier or contractor auditing experience preferred.
- Sterile product manufacturing knowledge preferred.
- Biopharmaceutical experience a plus.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER:Hannah Cihlar

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V.

J2W: HC, CLINICAL, MONJOB

TAXTERM: CON_W2J2WSEMW

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SFSF: LS