SUMMARY OF FUNCTIONS:
Assure that all laboratory equipment is maintained properly in accordance with cGMPs, SOPs, industry guidelines/expectations and manufacturer’s requirements.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Manages instrument and equipment calibration, preventative maintenance and qualification programs. Ensures compliance to cGMPs, SOPs, industry expectations and manufacturer’s requirements.
- Coordinates and manages vendor activities ensuring compliance to internal SOPs, industry standards and manufacturer requirements. Reviews documentation and work performed (protocols, reports, test records/scripts, certificates, etc.) for accuracy and cGMP compliance.
- Maintains current electronic calibration/PM tracking software and environmental chambers monitoring software.
- Creates and modifies necessary SOPs. Aids laboratory operations in the creation or modification of operational SOPs.
- Performs investigations into calibration/PM/Qualification related deviations. Determines appropriate root causes and implements necessary Preventative and Corrective Actions.
- Performs gap analysis and risk assessment on new and existing instrumentation/equipment with respect to manufacturer’s requirements and current industry requirements. Aids in development of remediation plan and performs assigned tasks.
- Works with engineering, quality, and laboratory personnel in evaluation of new instrument/equipment needs and selection.
- Considered instrument/equipment SME with respect to calibrations, preventative maintenance and qualification requirements. Supports client and regulatory audits.
- Creates necessary Training programs and performs necessary Training.
- Prepares and maintains required records and quality related documentation.
Reports to the Director, Quality Assurance.
EDUCATIONAL OR SKILL REQUIREMENTS:
Four year degree in Chemistry, Engineering or related scientific field.
Three to five years of relevant experience in a FDA regulated work environment including responsibilities related to calibration, preventative maintenance and qualification of instruments/equipment.
Competencies include: planning and organizational skills, problem analysis, judgment, team work. Computer skills especially related to Microsoft Office and typical Quality system software. Detail oriented and a clear understanding of cGMP requirements.
All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.