Senior Analyst, Laboratory Quality Control

Role Summary

Senior Analyst, Laboratory Quality Control performs quality laboratory testing required for the manufacturing process, utilities, raw materials, in-process samples, and final product in both microbiological and analytical laboratories. The role includes conducting microbiological and analytical testing (including bio burden, endotoxin, TOC, pH, conductivity, HPLC, Gel Electrophoresis, DNA), supporting method transfer, equipment qualification, and process validation, while ensuring compliance with regulatory and safety standards. The position requires independence, attention to data integrity, and the ability to work in a regulated environment, including areas requiring select agents.

Responsibilities

• Understand Regulations and business processes required to maintain Laboratory Data Integrity.
• Maintain and comply with Laboratory Documentation and Computerized Systems Data Integrity requirements.
• Adhere to cGMP requirements.
• Adhere to and supports all EHS & E standards, procedures and policies.
• Responsible for the timely completion of assigned laboratory testing.
• Ensure that all test equipment is used and maintained correctly.
• Able to work independently.
• Perform environmental monitoring in cleanrooms within the manufacturing area.
• Collect water samples throughout the manufacturing facility and test for bioburden and endotoxin.
• Perform bioburden and endotoxin for final drug substance.
• Knowledge in general microbiology preferred (Gram-stain, spore stain, streaking, growth promotion…).
• Able to work in an environment where respirator is required to be worn during production for at least 4 hours.
• Position requires constant body movement such as lifting, carrying equipment during environmental monitoring, pushing carts, doors.
• Able to accommodate weekend and holiday work as required by the manufacturing schedule.
• Participate in method transfers and validations as needed.
• Authoring and review of documents such as protocols, reports, test methods, SOPs.
• Owning and supporting cGMP routine testing by owning quality system records required for deviations, laboratory investigations, CAPAs and out – of -specification (OOS) results
• Support the qualifications of new laboratory equipment.
• Responsible for daily activities such as waste disposal, glasswasher, autoclave runs
• Able to maintain accurate inventory records of toxin during usage.

Qualifications

• Associate degree in science (major in Biology, Chemistry, Microbiology or Medical Technology) and five (5) years of relevant laboratory experience; or bachelor’s degree in science (major in Biology, Microbiology or Chemistry), and three (3) years of relevant laboratory experience.
• Experience in the general microbial and analytical testing/methodology (e. g. endotoxin, bio burden, HPLC, Gel Electrophoresis).
• Basic knowledge of laboratory techniques and laboratory instruments.
• Basic knowledge of computerized systems.
• Basic verbal and written communication skills in English.