Overview
Sr Quality Assurance Associate Jobs in Berkeley Heights, NJ at Breckenridge Pharmaceutical Inc
Full Job Description
Breckenridge Pharmaceutical develops and markets high-quality, added-value and cost-effective generic drugs in the United States. Our products are developed in the group’s own R&D facilities and through strategic partnerships with manufactures from around the world.
RESPONSIBILITIES
Support management of the SOP system, including writing/revising and maintaining SOPs, SOP Tracking and SOP Training
Participate in the review and internal tracking of manufacturers’ change controls
Support product quality complaints system including classification of complaints, complaint response letters issuance and notification to manufacturers
Participate in the QA review and internal product launch process for ANDA drug product, OTC, Dietary Supplement and Medical Food products
Support the QA management in quality investigations relating to quality-related complaints, as required
Product Quality Reviews, including review of manufacturers’ reports of annual product reviews, as required
Market distribution process
Conduct batch record reviews, as required
JOB REQUIREMENTS
Education:
BS required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)
Experience:
Minimum 5 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems
Required:
Knowledge of quality and compliance for drug production.
Knowledge of cGMP regulations (21 CFR 210 and 211 and 21 CFR 110 and 111)
Attention to detail and organizational skills
Strong written and verbal communication skills
Computer skills required: Microsoft Word, Adobe Acrobat, Microsoft Excel, Outlook
Title: Sr Quality Assurance Associate
Company: Breckenridge Pharmaceutical Inc
Location: Berkeley Heights, NJ
Category:
