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General Description:

Manages all Quality Control (QC) laboratory instrumentation activities to support GMP manufacturing, testing and release of materials, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures to support GMP manufacturing, ensuring the accuracy and reliability of laboratory instruments to minimize downtime.

Essential Functions of the job:

+ Manage/perform the calibration, verification, and qualification of basic laboratory instruments and equipment, including but not limited to balances, pH meters, centrifuges, etc.

+ Provide dedicated support for equipment life cycle management- calibration and maintenance scheduling, and documentation

+ Management of vendor contracts and relationships for equipment needing specialist service, including but not limited to HPLC, GC, spectrophotometers.

+ Ensure all calibration activities comply with regulatory guidelines (e.g., cGMP, USP/EP, etc.).

+ Maintain detailed records of calibration, maintenance, and repair activities, including calibration certificates and reports.

+ Support the qualification of new laboratory instruments, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

+ Generate and review qualification protocols and reports.

+ Manage the inventory of calibration standards and supplies.

+ Perform routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, specifications generation and revision, record keeping, etc.

+ Lead investigations of equipment out-of-tolerance (OOT), discrepancies, errors, and failures.

+ Implement corrective actions and preventive actions (CAPAs).

+ Assist in the preparation for internal and external GMP audits related to instrument calibration.

+ Train other junior level analysts and new hires.

+ Subject matter expert in one or more areas of required testing.

+ Undertake any other duties as required.

Core Competencies, Knowledge, and Skill Requirements

+ Proficiency in calibrating and troubleshooting a variety of laboratory instruments.

+ Working knowledge and experience with laboratory instrumentation, such as GC, HPLC, UPLC, titrators, Raman, UV spectrophotometer, FTIR, PCR, etc.

+ Working knowledge of laboratory operations and workflows in the pharmaceutical industry.

+ Working knowledge with USP/EP, ICH Guidelines and cGMP/EU GMP.

+ Strong knowledge of regulatory requirements for data management and compliance.

+ Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.

+ Strong leadership/team management skills and experience.

+ Credible and confident communicator (written and verbal) at all levels.

+ Strong analytical and problem-solving ability.

+ Hands-on approach, with a ‘can do’ attitude.

+ Ability to prioritize, demonstrating good time management skills.

+ Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.

+ Self-motivated, with the ability to work proactively using own initiative.

+ Committed to learning and development.

Significant Contacts

+ Interacts with all levels of BeOne employees.

**Supervisory Responsibilities:** N/A

Experience/Education Required:

+ Bachelor of Science degree and 5+ years of experience in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility required.

+ Bachelor’s in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, Engineering or related scientific discipline preferred.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.