Department: Quality Assurance
Location: Hybrid - local Berkeley Heights NJ
Employment Type: Full-Time
Job Classification: Non-Exempt
Salary: $130k plus competitive benefits
Mission
Under the supervision of QA management, the Senior Associate, Quality Assurance will support document review, SOP and training management, batch market distribution, and quality system functions to ensure compliance with regulatory standards.
Key Responsibilities
- Manage the SOP system including drafting, revising, tracking, and coordinating SOP training.
- Review and track manufacturers’ change controls internally.
- Support the product quality complaint system: classify complaints, issue response letters, and notify manufacturers.
- Participate in QA review processes and support internal product launches for ANDA drug products, OTC, dietary supplements, and medical food products.
- Assist QA management with quality investigations related to product complaints.
- Review and assess Product Quality Reviews and manufacturers’ Annual Product Review reports.
- Manage documentation and support activities related to market distribution.
- Conduct batch record reviews as needed.
Job Requirements
Education:
- Bachelor’s degree in a relevant scientific or technical field (e.g., Biology, Chemistry, Pharmacy, or related discipline) required.
Experience:
- Minimum of 5 years’ experience in the pharmaceutical industry, focused on Quality Assurance or Quality Systems.
Skills & Competencies:
- Strong understanding of quality systems and regulatory compliance in drug manufacturing.
- Working knowledge of cGMP regulations (21 CFR Parts 210, 211, 110, and 111).
- Excellent attention to detail, organizational, written, and verbal communication skills.
- Proficiency in Microsoft Word, Excel, Outlook, Adobe Acrobat.
- Experience with systems such as SAP and AssurX preferred.
- Fluency in English required.
External Relations:
- Interacts with external partners, suppliers, and manufacturers as necessary.
Direct Reports:
- None
Key Performance Indicators (KPIs)
- Timely and accurate SOP updates and training compliance.
- On-time complaint processing and resolution.
- Successful support of product launches and QA documentation.
- Quality and timeliness of batch record and change control reviews.
Equal Opportunity Employer
Randstad is an equal opportunity employer and is committed to diversity and inclusion. We welcome applicants of all backgrounds and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, protected veteran status, or any other legally protected group status.
Accommodation Statement
We are committed to ensuring an accessible application and interview process for all. If you require a reasonable accommodation at any stage of the process, please contact us at HRsupport@randstadusa.com.
Compensation and Benefits
The compensation offered will be based on a variety of factors, including but not limited to education, experience, location, job responsibilities, and applicable certifications. Randstad offers a comprehensive benefits package that includes healthcare, an incentive and recognition program, and a 401(k) plan with employer contribution (benefits eligibility may vary).
Posting Timeline
This job posting will remain open for 30 days from the date of publication.