Quality Control Analyst (Virology)

PURPOSE OF THE JOB

This position will focus on providing support to the Virology Team Leader for method transfer/ validation and routine Viral product testing including inactivation of antigens test, virus cell culture assay to determine the virus titre, and extraneous substances.

REQUIRED OUTCOMES FOR THE BUSINESS UNIT

Consistent work practices and approach to systems and processes

Meet regulatory and corporate requirements with regard to quality and EHS compliance with a focus on continual improvement

Continuously learning to meet changing business and individual needs

Product continually meets required standards of quality, safety, and efficacy

The Role/ Job Description

• Performing routine testing including inactivation of viral antigen, virus cell culture assay for potency estimation, extraneous agents, mycoplasma screening, etc
• Assist and participate in tech transfer or validation of Viral product testing methods.
• Updating specifications and test records as required
• Participating in additional product testing, such as stability samples as required
• Ensure efficient, precise, and accurate reporting of test results in LIMS.
• Supporting laboratory-based projects
• Maintaining laboratory housekeeping
• Participating in laboratory investigations for out of specification results, deviations, and non-conformances
• Support analyst training as required.
• Maintain laboratory quality standards by ensuring a high standard of work conducted at all times.
• Assist with preparing, reviewing, and updating Standard Operating Procedures and Procedures and forms for Testing.
• Ensure equipment and facilities are maintained/prepared in accordance with approved procedures.
• Adherence to GMP and GLP principles
• Adherence to all safety precautions

Your skills and experience

• Bachelor’s degree in science or a relevant scientific discipline (Virology, Pharmaceutical Science, Microbiology, Biology, Biochemistry, etc.)
• 3+ years of experience in the pharmaceutical/veterinary pharmaceutical, biotechnology, or related industry with notable exposure to GMP, GLP, and viral product (vaccine/antigen) testing.
• Practical experience with a microbiology lab specifically viral antigen/vaccine testing and cell culture assay is highly regarded.
• Practical experience with Viral test method validation including protocol and report writing is highly regarded.
• Understanding of the USP, BP & EP pharmacopoeias.
• Knowledge of GMP, GLP, aseptic technique, and the regulatory environment.
• Understanding of Viral Product Testing Requirements.
• Attention to details is highly regarded.

KEY ACCOUNTABILITIES

· Support the QC Virology Team Leader for routine testing and test method transfers from local and global GMT labs

Continuous Supply

· Testing of manufacturing materials to schedule

· Performing routine testing (e.g. inactivation of antigens test, virus cell culture assay to determine the virus titre and extraneous substances)

· QC laboratory sample management

· Stock control of Standards and Controls

· Data entry into ZLIMs

· Method transfers to and from the laboratory site

Quality and Compliance

· Ensure testing is assessed against specifications

· Microbiological, viral and/or biochemical method validation

· Ensure OOS/OOT/OOE are reported and investigated.

· Ensure analytical equipment is qualified and maintained

· Laboratory compliance (equipment calibration & qualification, QC IT tool & automation system validation)

· Maintaining up to date laboratory records for all testing, analytical work and investigations performed.

EHS

· Support EHS Department to create and maintain safe, healthy and environment-friendly working mode in QC Department and ensure that all employees are properly trained.

Operational Excellence

· Support the Quality Control Manager to achieve each of the GMS KPIs aligned with Zoetis values and leadership competencies.

ESSENTIAL QUALIFICATIONS & EXPERIENCE

Bachelor of Science or equivalent with majors in Virology, Pharmaceutical Science, Microbiology, Immunology or Biotechnology

Previous experience in a virology lab