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General Laboratory Activity

• Complies with laboratory safety requirements

• Complies with laboratory related regulation and requirements

• Preparation/Revision and review of GMP/GLP documents (Test method documents, Lab notes (Worksheet), Procedures)

• Usage and Management of GMP document / Assure that GMP/GLP documents are properly maintained and/or archived

• Internal and external audit/inspection Preparation and Response

• Other laboratory Support activity (e.g., housekeeping)

(The responsibilities listed below may be assigned based on business needs, organizational priorities, and the individual's qualifications and competencies.)

QC Laboratory Test Activity

• Perform QC testing in compliance with GMP and corporate requirements/procedures.
• Review analytical data and test results.
• Conduct and/or support laboratory investigations when issues occur.
• Perform data integrity activities in accordance with applicable regulations and J&J requirements.
• Utilize electronic systems (e.g., LIMS, MES, LES, Empower) for execution, review, and documentation of laboratory activities.

QC Laboratory Management

• Laboratory system administration (LIMS. Empower, etc.)

• Lab equipment management (Qualification (Instrument Decommissioning included), Calibration, Maintenance, etc.)

• Coordinate/Document/Handling non-conformances, corrective actions (CAPAs) and changes (change control management)

• Lab activities for creating a Safe Lab Environment

• Accompany visitors and provide training to visitors

• Manage and Review of GMP data in compliance with GMP and corporate requirements/Procedures

• Keep supervisor informed of task status and issues

• Complete corrective and preventative actions (CAPA) as assigned

Minimum Qualification

• Minimum bachelor’s degree (in Chemistry, Chemical Engineering, Life Science, Pharmaceutical Engineering, or related fields)

• Understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and compendial (USP, EP, JP, etc.) requirements

• Good Interpersonal communication and Collaboration skills
• Demonstrated ability to organize and prioritize workload

Other Requirements (Preferred)

• Experience in pharmaceutical industry

• Experience in QC department

Required Skills:

Preferred Skills: