Senior Specialist, QC Microbiology

Major responsibilities

• Perform microbiological testing-related work, including pharmaceutical microbial limits testing, sterility testing, bacterial endotoxin testing, cleaning validation, cleanroom environmental monitoring, and strain bank/library testing.
• Participate in developing microbiological quality standards and standard operating procedures (SOPs) for analytical methods related to material control.
• Participate in developing microbiological quality standards and SOPs for analytical methods related to in-process control, intermediates, and finished products.
• Propose or participate in analytical method optimization; participate in drafting method qualification/verification and method transfer protocols; issue method qualification and method transfer reports.
• Participate in developing stability study protocols for intermediates and finished products; organize personnel to conduct stability study experiments and review stability data.
• Organize training for microbiology testing technicians, including pre-job/onboarding training for new employees and on-the-job training/retraining for existing employees (e.g., GMP regulations, professional technical knowledge, microbiology testing-related SOPs, etc.).
• Participate in formulating GMP-compliant area management procedures and workflows for the microbiology laboratory and ensure normal operation of the laboratory areas.
• Organize personnel, as planned, to perform sample aliquoting for raw materials, excipients, packaging materials, in-process products, intermediates, finished products, and stability samples; manage samples under testing.
• Organize personnel, as planned, to perform testing; complete testing records, review testing results, issue test reports, and promptly report to upper management.
• Organize personnel, as planned, to conduct cleanroom environmental monitoring; promptly capture environmental isolates, perform isolation, identification, and library creation; compile environmental monitoring data, issue environmental monitoring reports, and promptly report to upper management; organize personnel to participate in cleanroom environmental qualification/validation.
• Organize personnel, as planned, to perform data collection, statistics, and trend analysis for process gases and cleanroom environmental monitoring; support completion of product (annual) quality reviews.
• Where microbiology-related outsourced testing is required, participate in supplier audits, execute contracts, arrange personnel for sample submission, collect outsourced test reports in a timely manner, and perform review/sign-off.
• Procure microbiology testing-related reagents, consumables, reference standards, and microbial/toxin strains as planned, ensure normal testing needs are met, and store/manage them per requirements.
• Organize personnel to perform horseshoe crab reagent (LAL) sensitivity requalification for new lots, suitability testing for culture media, and manage prepared test solutions per relevant requirements.
• Organize personnel to manage the testing strain bank/library.
• Organize personnel, as planned, to carry out sterilization validation and cleaning validation.
• For abnormalities identified during testing or outsourced testing, promptly report to upper management and organize OOS/deviation investigations; if confirmed as not attributable to, or with no traceable root cause within, the laboratory, assist in investigating other potential causes.
• Ensure proper operation of microbiology-related instruments and equipment; arrange regular maintenance and calibration; promptly report malfunctions for repair.
• Cooperate with internal and external audits and complete required corrective actions within planned timelines.
• Complete other laboratory-related tasks assigned by management on schedule.

Education, Qualifications, Skills and Experience

• Education: Bachelor’s degree or above in microbiology or related disciplines.
• Experience: Minimum three years of experience in pharmaceutical testing or pharmaceutical quality-related work.
• Regulations and Standards: Familiar with GMP regulatory guidelines and major pharmacopeias of various countries; familiar with quality management systems.
• Laboratory Practices: Proficient in pharmaceutical microbiology laboratory practices, including microbial limits testing, sterility testing, bacterial endotoxin testing, cleaning validation, environmental monitoring in cleanrooms, strain bank/library testing, and related techniques.
• Digital Skills: Proficient in computer use and Microsoft software.
• Soft Skills: Strong communication, presentation, organization, and coordination skills, with good English proficiency in listening, speaking, reading, and writing.

Date Posted

04-1月-2026

Closing Date

29-6月-2026

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.