- Pre-production preparation, review, and approval of batch records for various cGMP OTC, medical device, and pharmaceutical products
- Post-production batch record review and approval
- Review production data and draft COA and COC from this data using approved templates
- Trend data collected from batch records and update periodically
- Diagnose and propose areas of growth within current QMS
- Print, scan, file, and archive batch records and other quality documents
- Support the Director of Quality with quality-related activities
- Work smoothly within a devoted team
- Bachelor's degree in science related field (MS preferred)
- 2+ years in like or similar function in pharmaceutical or medical device industry cgmp
- Strong communications skills and proficiency with the English language, specifically scientific, pharmaceutical, and medical device nomenclature
- Experience working in a cGMP environment
- Experience working with and familiarity with cGMP quality documentation such as batch records, NCRs, CAPAs, SOPs, DCRs, COAs, COCs, etc.,
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
Document Control Specialist - Stratford, United States - Actalent
Description
Description:
Skills: qa/qc, batch record review, gmp, fda, pharmaceutical, medical device, coa, cmp, capa
Top Skills Details: qa/qc,batch record review,gmp
Additional Skills & Qualifications:
Experience Level:
Intermediate Level
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
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