Quality Control Microbiology testing
About The Position
This position performs microbiological testing and related analytical functions in the QC microbiology laboratory. Testing follows approved methodologies to help ensure that the safety, quality, purity, and stability of products, components, and in-process stages comply with approved specifications. The role also contributes to data trending and periodic reports, highlights technical or equipment issues, and works closely with the Microbiology Manager. The microbiology team provides flexible, cross-functional support for manufacturing processes and quality investigations. The position offers opportunities to develop skills across the operational microbiology laboratory. The role includes analytical testing, QC data review, documentation, investigation and CAPA participation, laboratory and equipment upkeep, training, audit readiness, and maintenance of local procedures, all in accordance with applicable cGMP, cGLP, HSE, and data integrity requirements.
Requirements
- Bachelor's degree in Life Sciences, Biology, Chemistry, or a related field.
- At least 1 year of laboratory or manufacturing experience.
Nice To Haves
- Experience in a pharmaceutical or related industrial environment.
Responsibilities
- Execute analytical testing in a timely manner and meet committed schedules.
- Perform assigned work in accordance with cGMP and HSE requirements and applicable instructions, procedures, and records.
- Record required raw data, calculations, and other task-related information in compliance with cGMP and data integrity requirements.
- Maintain training and qualification to perform assigned analytical testing on samples such as raw materials, in-process drug substance samples, and environmental monitoring samples.
- Review data from tests executed by other analysts when delegated, in a timely manner and according to committed schedules.
- Promptly inform the manager of quality or HSE events, including deviations and OOx, so that investigations and impact assessments can be conducted appropriately.
- Participate in investigations in which the employee is involved, supporting appropriate investigation and impact assessment.
- Execute assigned CAPAs related to remediation plans and continuous improvements.
- Maintain the laboratory, facilities, and instruments in an appropriate quality and safety condition.
- Contribute to trending environmental monitoring and utilities monitoring data and assist with or author periodic reports.
- Train team members in analytical testing and documentation when qualified as a trainer, supporting adherence to local and global SOPs and cGMP requirements.
- Keep the laboratory audit-ready and represent the lab team during audits and inspections.
- Revise and update local procedures as necessary to align with cGMP/cGLP guidelines and improve usability for laboratory activities.
- Build remediation plans related to inspection-readiness gaps, findings, and deviations.
Benefits
- Health and wellbeing benefits, including high-quality healthcare, prevention, and wellness programs.
- At least 14 weeks of gender-neutral parental leave.
- Company employee benefit programs; additional benefits information is available through the company.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
