26 applicants

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Company

Original Job Post

Renaissance Lakewood, LLC · 3 days ago

QA Specialist

Lakewood, NJ

Full-time

Onsite

Entry, Mid Level

$72K/yr - $90K/yr

3+ years exp

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Health CareManufacturing

H1B Sponsorship

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Responsibilities

Review manufacturing batch records, testing results, and deviation reports

Interact with other departments to address review observations

Release drug product, drug product components, and container-closures

Interact with customers on batch record reviews and batch releases

Attend department meetings on batch record review and releases

Maintain and report quality metrics on batch record review and releases

Review and write standard operating procedures

Review quality system documents (change controls, validation, complaints)

Review master batch records and maintain records

Process, investigate, and follow-up on product complaints

Ensure quality and timely review of notifications, deviations, and CAPAs; both commercial and development

Final closure and delivery of PRs to the client

Creation of, follow up and closure of CAPAs

Ensure extensions for PRs are completed adequately

Work with other departments to ensure quality and timeliness of deviations/notifications

Lead triage and notify clients of new PRs

Attend/host client meetings, prepare detailed agenda, communicate directly with client, manage client requests/follow up on documents

Prepare metrics

Perform other tasks as requested by management.

Qualification

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Pharmaceutical Industry Experience

Required

Bachelor’s Degree (BA or BS), preferably in a Natural Science

Minimum of 3 years of relevant experience in the pharmaceutical industry

Company

Renaissance Lakewood, LLC

Renaissance is a US-based contract development and manufacturing organization (CDMO) for pharmaceutical and biotech companies.

Founded in 1979

Lakewood, New Jersey, USA

201-500 employees

https://www.renpharm.com

H1B Sponsorship

Renaissance Lakewood, LLC has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

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Trends of Total Sponsorships

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2020 (2)