quality analyst micro

$52,000 - $62,400/Yr

Randstad - Billerica, MA

Full-time - Entry Level

Billerica, MA

Administrative and Support Services

About the position

The Quality Analyst position in North Billerica, Massachusetts, is a contract role focused on performing quality control testing in a laboratory setting. The role involves ensuring compliance with SOPs and cGMP guidelines, verifying data accuracy, and assisting with audit readiness. The ideal candidate will contribute to continuous improvement efforts and promote safety in the workplace while working with potentially hazardous materials.

Responsibilities

• Perform testing on incoming materials, finished products, and stability studies in the QC Laboratory.
• Perform routine QC testing in accordance with SOPs and cGMP guidelines, with some supervision required.
• Verify data to ensure accuracy and perform approval upon discretion of supervisor.
• Assist with audit readiness of laboratory area and calibration and maintenance of laboratory equipment.
• Utilize electronic systems such as LIMS and document/equipment management software.
• Author SOP changes and participate in change controls, CAPAs, and other quality systems.
• Resolve routine problems by utilizing appropriate resources and assist in investigations.
• May assist on special projects as needed and help with continuous improvement.
• Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
• Actively promote safety rules and awareness, reporting and correcting safety and environmental hazards.
• Demonstrate good safety practices at all times, including the appropriate use of protective equipment.

Requirements

• Typically requires 1-3 years of previous experience in the pharmaceutical industry or related GMP environment.
• Requires a BA/BS degree in a related scientific discipline (e.g., chemistry, biology) or equivalent combination of education and experience.
• Familiarity with aseptic technique is preferred.
• Ability to perform routine Environmental Monitoring and utilities testing.
• Experience in sterility, microbial limits, and Endotoxin testing, with the ability to identify and trend microorganisms.

Nice-to-haves

• Flexibility with scheduling requirements, including shifts, overtime, weekends, and holiday coverage.
• Ability to lift 50 lbs.

Benefits

• Health insurance
• Incentive and recognition program
• 401K contribution