Quality Assurance Specialist

Randstad Life Sciences US; Newark (NJ); Hybrid; USD 115,000 - 135,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Director of Delivery for Enterprise Accounts. This role involves managing quality assurance processes, ensuring compliance with regulatory standards, and supporting internal product launches. The ideal candidate will have a strong background in quality systems and at least 5 years of experience in the pharmaceutical field. This hybrid position offers a comprehensive benefits package and opportunities for professional growth.

Benefits

Medical insurance

Vision insurance

401(k)

Qualifications

• Minimum of 5 years’ experience in the pharmaceutical industry focused on Quality Assurance.
• Strong understanding of quality systems and regulatory compliance.

Responsibilities

• Manage the SOP system including drafting and coordinating training.
• Support the product quality complaint system.

Skills

Attention to Detail

Organizational Skills

Communication

Education

Bachelor’s degree in a relevant scientific or technical field

Tools

Microsoft Word

Excel

Outlook

Adobe Acrobat

SAP

AssurX

Job description

Direct message the job poster from Randstad Life Sciences US

Director of Delivery, Enterprise Accounts

Department: Quality Assurance

Location: Hybrid - local Berkeley Heights NJ

Employment Type: Full-Time

Job Classification: Non-Exempt

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.
• 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 [e-mail].

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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science and Quality Assurance

• Industries

  Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at Randstad Life Sciences US by 2x

Inferred from the description for this job

Medical insurance

Vision insurance

401(k)

Get notified when a new job is posted.

Sign in to set job alerts for “Quality Assurance Manager” roles.

New York City Metropolitan Area $115,000.00-$135,000.00 2 weeks ago

Senior Quality Assurance Manager - Sterile Eyecare (Tarrytown, NY)

New York City Metropolitan Area 1 week ago

Imaging Quality Assurance Manager, Amazon Private Brands

Manhattan, NY $58,700.00-$63,301.00 1 year ago

New York City Metropolitan Area $90,000.00-$140,000.00 1 week ago

Sr. Director, Quality Assurance Engineering

Quality Assurance Manager - Civil & Utility

Manhattan, NY $135,000.00-$165,000.00 1 day ago

Manager, Corporate Quality (Post-Market / External Quality)

Quality Assurance & Food Safety Manager (Flavor)

SVP, HR ACT - Quality Assurance, Monitoring & Testing Sr. Lead Analyst

Jersey City, NJ $100,244.00-$170,415.00 2 weeks ago

VP, HR ACT - Quality Assurance, Monitoring & Testing Lead Analyst

Sr. Engineer, Quality Operations (Wayne, NJ)

Operations Program Manager, Quality Control

New York City Metropolitan Area 2 days ago

Account Receivable / Medical Billing Supervisor

Yonkers, NY $70,000.00-$73,000.00 1 week ago

Quality Assurance Manager - Clinical Pathology

New York, NY $125,000.00-$150,000.00 1 day ago

Quality Assurance Manager - Clinical Labs Pathology - New York State Licensed

Livingston, NJ $70,920.00-$117,990.00 2 months ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.