Document Control Specialist

Document Control Specialist

Onsite in Stratford, CT

Description:

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

Skills:

qa/qc, batch record review, gmp, fda, pharmaceutical, medical device, coa, cmp, capa

Additional Skills & Qualifications:

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.,

Knowledge of industry guidance and regulations from FDA, ICH, ISO, etc.,

Experience with data review, compilation, and trending

Strong editing skills

Strong proficiency with Microsoft product suite

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

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• 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

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.