QA/ Documentation Specialist

Principal Specialist, Packaging Training
Location: Athens, GA

Contract Duration: 6 months (Possible Extension)

Pay Rate Range: $30.66 - $32.85/hr (W2)

Work Authorization: USC or GC only

WHAT THE CLIENT DOES?
A global, research-driven pharmaceutical company that focuses on developing innovative medicines in areas such as human pharmaceuticals, animal health, and biopharmaceutical contract manufacturing.

WHAT WE DO?
Established in 2000, VARITE is an award-winning minority business enterprise providing global consulting & staffing services to Fortune 1000 companies and government agencies. With 850+ global consultants, VARITE is committed to delivering excellence to its customers by leveraging its global experience and expertise in providing comprehensive scientific, engineering, technical, and non-technical staff augmentation and talent acquisition services.

HERE’S WHAT YOU’LL DO
Job Summary:

Lead the Packaging (PKG) documentation team in order to support the production line as required through batch documentation review, deviations, change controls, CAPAs, and document creation/revision in compliance with procedures and regulatory requirements.

Develop, review, and maintain an up-to-date training program to meet all compliance and packaging requirements.

Maintain supplemental training records and ensure all personnel are up to date on all compliance requirements.

Track training primarily through the LOS system.

Track OJT separately outside of LOS and implement effective CAPAs to mitigate potential issues in deviations and audits.

Product Release

Oversee the review/approval of manufacturing records, deviations, product holds/dispositions, change controls, CAPAs, document creation/revision, etc. as needed to release product according to applicable procedures.

Act as PKG internal SME for routine production issues leading toward deviations, product dispositions, and response corrections needed to continue production.

Supervisor areas

Lead PKG document specialist through daily operations.

Conduct or assist with performance evaluations and development discussions.

Skills

Perform all company business in accordance with all regulations (e.g., EEO, USDA, EU, EMA etc.) and company policies and procedures.

Report violations immediately to management when noted/observed.

Demonstrate high ethical and professional standards with all business contacts to maintain the company's excellent reputation in the community.

Education

Bachelor’s degree from an accredited institution in a relevant scientific discipline.

BENEFITS

Health Insurance: Medical, dental, and vision coverage.

Retirement Plans: Participation in a company-sponsored retirement savings plan.

Legal Service Plans: Access to attorneys for legal advice and representation.

VARITE is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

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