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 standard operating procedures (SOPs) and current Good Manufacturing Practices (cGMP) while contributing to the overall quality assurance processes within the life sciences sector. The position offers an opportunity to work with prestigious biopharma companies and make a significant impact in the industry.

Responsibilities

• Perform testing on incoming materials, finished products, and stability studies in the QC Laboratory.
• Conduct routine QC testing in accordance with SOPs and cGMP guidelines, with some supervision required.
• Verify data accuracy and perform approvals at the discretion of the supervisor.
• Assist with audit readiness of the 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 using appropriate resources and assist in investigations.
• May assist on special projects and contribute to continuous improvement efforts.
• Train on and maintain knowledge of current regulatory requirements and relevant internal procedures.
• Demonstrate good safety practices and promote safety rules and awareness in the workplace.

Requirements

• Typically requires 1-3 years of previous experience in the pharmaceutical industry or a 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 techniques and routine environmental monitoring.
• Ability to perform sterility, microbial limits, and endotoxin testing, and identify and trend microorganisms.
• Must be able to lift 50 lbs.

Nice-to-haves

• Flexibility with scheduling requirements, including shifts, overtime, weekends, and holiday coverage.
• Some non-routine travel may be required.

Benefits

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