USA - Quality Control Analyst

Quality Control Analyst - Contract - Minneapolis, MN

Ensure quality, drive compliance-join us as a QC Analyst and keep standards at their peak.

Proclinical is seeking a Quality Control Analyst for a contract position located in The US. This position requires a proactive individual with strong analytical skills and the ability to work collaboratively in a fast-paced environment.

Primary Responsibilities:

The successful candidate will be responsible for performing routine and specialized quality control testing, maintaining laboratory operations, and ensuring compliance with regulatory standards.

Skills & Requirements:

• Degree in Life Sciences with relevant laboratory coursework.
• Experience in a regulated environment is preferred.
• Proficiency with laboratory instrumentation and software systems.
• Strong understanding of cGMP manufacturing and laboratory safety procedures.
• Effective communication and teamwork skills.
• Knowledge of QC analytical techniques (e.g., HPLC, UPLC, pH, TOC), bioassays (e.g., ELISAs, cell-based assays), and microbiological methods (e.g., endotoxin, bioburden, environmental monitoring).
• Ability to work independently and solve moderately complex problems.
• Physical ability to perform laboratory tasks, including lifting materials up to 30 pounds and working in cleanroom environments.
• Willingness to travel occasionally and participate in on-call rotations if needed.

The Quality Control Analyst's responsibilities will be:

• Perform and review routine in-process drug substance and stability test methods.
• Operate laboratory instruments and systems such as LIMS, SoftmaxPro, Charles River Endoscan, MODA, and Empower.
• Conduct facility monitoring, including Environmental Monitoring and Critical Utilities, as well as product testing.
• Maintain laboratory operations, including cleaning, supply ordering, reagent preparation, stocking, and waste disposal.
• Author and manage quality system events, including laboratory investigations, deviations, CAPAs, and change controls.
• Ensure data integrity and compliance with SOPs, specifications, and cGMP regulations.
• Train new team members on standard procedures and practices.
• Perform equipment maintenance and calibrations as required.
• Participate in cross-functional teams and contribute to problem-solving and decision-making processes.
• Draft and revise SOPs and initiate procedural changes.
• Complete mandatory training and adhere to safety protocols.

If you are having difficulty in applying or if you have any questions, please contact Anderson Maldonado at a.maldonado@proclinical.com

If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.

Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.

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