Quality Control Analyst II

The Quality Control Microbiology Analyst II plays an important role in supporting Quality Control (QC) operations to ensure the highest standards of quality and regulatory compliance throughout all phases of product development and commercialization.

This position involves performing both routine and non-routine microbiological testing, contributing to data trending, investigations, and laboratory operations. By ensuring timely and accurate execution of QC activities, the Analyst II helps maintain efficient laboratory operations and compliance with project timelines.

Key Responsibilities:

• Perform routine and non-routine microbiological assays (e.g., bioburden, TOC, endotoxin, conductivity) to support critical utilities, in-process samples, and product release in compliance with established SOPs.
• Maintain current training records and complete assigned testing according to the QC schedule to meet departmental milestones.
• Support the maintenance and calibration of laboratory equipment and manage laboratory inventory to ensure smooth daily operations.
• Submit data promptly and accurately; may perform data review responsibilities to ensure timely reporting and data integrity.
• Perform role-specific assignments such as critical utility sampling, environmental monitoring, and product testing.
• Contribute to the revision and improvement of controlled documents (e.g., SOPs, work instructions, test methods) to maintain compliance and operational excellence.
• Adhere to internal policies, procedures, and regulatory standards (GMP, GLP, ICH) to uphold product quality and regulatory compliance.
• Collaborate with QC and cross-functional teams including Manufacturing, Materials Management, and Quality Assurance to support production and release activities.
• Participate in inspection readiness activities and assist during internal and external audits or inspections.
• Support and contribute to continuous improvement initiatives within the QC organization.
• Participate in quality events such as investigations, deviations, CAPAs, and change controls as needed.

Skills:

• Strong attention to detail and ability to follow direction in a dynamic work environment.
• Excellent teamwork and communication skills with a collaborative mindset.
• Demonstrated ability to prioritize and adapt to shifting business needs.

Education:

• Bachelor’s degree in Biology, Biochemistry, Chemistry, or related scientific discipline.
• Associate degree or Biotech Certificate with relevant experience may be considered.

Experience:

• Minimum of 2 years of experience in a regulated laboratory environment, preferably in Quality Control within the pharmaceutical or biotechnology industry.
• Hands-on experience or strong understanding of microbiological testing and environmental monitoring/critical utility (EM/CU) sampling.
• Experience supporting quality events such as investigations, deviations, CAPAs, or change controls preferred.
• Familiarity with data analysis tools and systems (e.g., LIMS, Excel, Word, PowerPoint).

• 7-month contract