We are working with a leading pharmaceutical manufacturing company to hire a QC Biologist.
This role supports Quality Control and Environmental Monitoring activities within a regulated biopharmaceutical manufacturing environment. The position combines technical writing responsibilities with hands‑on microbiology and cleanroom support activities to ensure compliance with cGMP and GLP standards. The successful candidate will manage documentation updates, support facility qualification activities, and contribute to routine environmental monitoring operations. Strong collaboration, attention to detail, and the ability to work independently in a fast-paced GMP setting are essential.
Key Responsibilities
Create, review, update, and maintain GMP documentation including SOPs, technical protocols, analytical methods, and laboratory reports.
Support Environmental Monitoring activities including routine EM sampling, water testing, EM plate reading, and facility PQ execution.
Collaborate with cross‑functional teams and business partners to ensure projects and documentation activities are completed on time.
Ensure compliance with cGMP, GLP, and documentation standards while maintaining accurate records within document management systems.
Assist with risk assessments, cleanroom qualification activities, and continuous improvement initiatives within the QC function.
Key Requirements
Bachelor’s degree in a Science or related discipline.
Previous biopharmaceutical QC experience with a strong focus on Environmental Monitoring and aseptic cleanroom operations.
Experience working within cGMP‑regulated pharmaceutical manufacturing and testing environments.
Proven technical writing experience, including preparation and review of GMP documentation.
Proficiency in systems such as LIMS and LMES; experience with SAP, Change Control, and CDOCS is advantageous.
Strong microbiology knowledge, communication skills, problem‑solving ability, and experience working independently in regulated environments.
This is a 12 month contract.
Due to the high volume of applications, we may not be able to respond to every applicant.
AscendPM do not forward candidate CVs to clients without prior consent.
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