Associate Quality Control/Specialist I Quality Control

AstraZeneca • Frederick, MD

5d • Onsite

About The Position

The Frederick Manufacturing Center (FMC) is a biologic manufacturing facility with over 800 employees that produces medicines for patients with cancer, respiratory diseases, and autoimmune conditions. The company describes FMC as a community-recognized workplace and emphasizes inclusion, collaboration, continuous learning, employee recognition, community outreach, and environmental and wellness programs.

The Associate Quality Control/Specialist I Quality Control role performs laboratory sampling and testing and supports routine testing of products and materials under supervision. The role helps generate laboratory results, maintains laboratory housekeeping and supplies, prepares samples, records results, and sets up, takes down, and cleans testing equipment and sites. It identifies equipment or testing issues, supports the availability of equipment and supplies, and enters evaluated data for compliance with specifications while reporting abnormalities. The employee follows SOPs and cGMPs, applies critical thinking to problems, and works under general supervision for routine tasks, receiving detailed instructions for new activities or special assignments.

The role also requires conduct consistent with company values and the Code of Conduct and supporting policies and standards. Employees must complete required training on time and report potential non-compliance issues. Responsibilities include supporting and monitoring team and third-party compliance, encouraging employees to raise concerns, and addressing and reporting instances of non-compliance as appropriate.

Requirements

• Associate level: high school diploma or equivalent plus 4 years of experience; alternatively, an associate's degree plus 2 years of work experience; or a bachelor's degree plus 0 years of experience.
• Specialist I level: bachelor's degree, with 0–5 years of experience; pharmaceutical industry experience is preferred.
• Read, understand, and follow SOPs and comply with cGMPs.
• Apply scientific methods and techniques to problem-solving.

Nice To Haves

• Bachelor's degree in a scientific, biotechnology, or pharmaceutical field of study.
• Hands-on experience with balances, pipetting, pH, osmolarity, UV/Vis, and ELISA.
• Self-motivation and ability to multitask.
• Excellent written and oral communication skills.
• GMP experience.
• Experience in the pharmaceutical industry.

Responsibilities

• Perform laboratory sampling and testing.
• Assist with or complete routine tests on products and materials and help generate laboratory results under supervision.
• Maintain laboratory housekeeping and stocking.
• Perform laboratory tasks such as sample preparation and recording results to meet the work plan.
• Set up and take down testing and other laboratory equipment and clean testing sites.
• Identify and highlight equipment and testing issues.
• Support the availability of appropriate equipment and supplies for testing.
• Enter data evaluated for compliance with specifications and report abnormalities.
• Read, understand, and follow SOPs and comply with cGMPs.
• Apply critical thinking to solve problems using scientific methods and techniques.
• Conduct activities and interactions consistent with company values and applicable policies and standards.
• Complete required Code of Conduct and policy training on time.
• Report potential non-compliance issues.
• Support and monitor compliance by team members and third parties, reinforce applicable policies and standards, foster an open culture for raising questions or concerns, and address and report non-compliance as appropriate.

Benefits

• Qualified retirement program (401(k) plan).
• Paid vacation and holidays.
• Paid leaves.
• Medical, prescription drug, dental, and vision coverage.
• Short-term incentive bonus opportunity.
• Eligibility for an equity-based long-term incentive program for salaried roles.
• Retirement contribution for hourly roles.
• Overtime pay for qualifying overtime hours for hourly and salaried non-exempt employees.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED