Quality Assurance Specialist

Astrix; New Jersey; On-site; USD 41,328 - 55,104; Full time

Job summary

A reputable staffing firm in New Jersey is seeking a Quality Assurance Specialist for a contract-to-hire position. The successful candidate will review and approve documentation, ensure compliance with GMP regulations, and collaborate with various departments. Candidates should have a Bachelor's degree in a scientific discipline and 2–5 years of experience in Quality Assurance within the biotechnology or pharmaceutical industry. Proficiency in Microsoft Office is preferred.

Qualifications

• 2–5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry.
• Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles.
• Experience reviewing QC data, raw material documentation, and stability reports.

Responsibilities

• Review and approve raw material documentation for accuracy and compliance.
• Perform raw material release activities in accordance with established SOPs and GMP requirements.
• Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing.

Skills

Attention to detail

Strong organizational skills

Teamwork

Communication skills

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Quality management systems (QMS)

LIMS

Job description

Quality Assurance Specialist

Type: Contract-to-hire

Shift: M-F, 1st Shift

Location: Middlesex County, NJ

Base pay range

$30.00/hr - $40.00/hr

Key Responsibilities

• Review and approve raw material documentation (e.g., Certificates of Analysis, specifications, vendor documents) for accuracy and compliance.
• Perform raw material release activities in accordance with established SOPs and GMP requirements.
• Coordinate and/or review raw material sampling to ensure proper identification, handling, and chain of custody.
• Review QC laboratory documentation and analytical data for accuracy, completeness, and compliance with applicable procedures and specifications.
• Review and track stability reports, ensuring timely completion, accuracy, and adherence to protocols.
• Support investigations, deviations, CAPAs, and change controls related to raw materials and QC data.
• Collaborate cross-functionally with Quality Control, Supply Chain, and Manufacturing to ensure smooth flow of materials and documentation.
• Participate in internal and external audits, as needed.
• Identify and support opportunities for continuous improvement in quality systems and documentation processes.

Qualifications

• Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry, Biochemistry, or related field) required.
• 2–5 years of experience in Quality Assurance within the biotechnology, biopharmaceutical, or pharmaceutical industry.
• Strong knowledge of GMP regulations (21 CFR Part 210/211) and quality system principles.
• Experience reviewing QC data, raw material documentation, and stability reports.
• Detail-oriented with strong organizational and documentation skills.
• Excellent communication and teamwork abilities.
• Proficiency with Microsoft Office and familiarity with quality management systems (QMS) or LIMS preferred.

This job description is a complete list of all desired skills, but not all are required. We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!