Execute IQ/OQ/PQ activities, data integrity assessments, and other lifecycle requirements for GMP analytical instrumentation including documentation following cGMP expectations.
Onboard new GMP analytical instruments and equipment.
Provide change control support of GMP analytical instrumentation, equipment, systems, and associated services.
Support administrator and periodic review needs for GMP instruments.
Stay current on Good Manufacturing Practices (cGMPs) guidelines, Good Laboratory Practices (GLPs), and exhibiting best practices within manufacturing, testing, safety, compliance, investigations, and procedures.
Create and follow SOPs as required to support activities in a cGxP environment
Support projects to onboard appropriate instrumentation.
Communicate with customers as necessary in order to progress work in a timely and appropriate fashion.
Perform duties in a safe manner with a focus on Zero Injuries.
Lead and/or participate in continuous improvement activities, including DI remediation.
Specific PPE requirements, including clean room gowning, may be required.
Minimum of BS degree in Biology, Chemistry, or related field plus 4 years experience in a GMP laboratory or similar field.
Experience in GMP QC laboratory, including trending of data, investigation management, and working in a regulated environment is required.
Able to work in a fast paced team environment with changing priorities
Excellent documentation skills
Experience with UV, HPLC, pH, Bioburden, Endotoxin, PCR, and other similar laboratory instrumentation and methodologies
Self-motivated and highly effective in a team-based environment
Effective oral and written communication skills
ADDITIONAL OFFER DETAILS
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EEO & Employment Eligibility
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N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.