Pfizer Senior Associate, Instrument Systems & Compliance in St. Louis, Missouri
- This role is responsible for the support of analytical instrumentation lifecycle needs in accordance with established SOPs, regulations, and Quality Standards following cGMP principles. This role will develop, execute and deliver validation services and documentation necessary to qualify and maintain analytical systems under Pfizer requirements and current regulations. Excellent written and communication skills, effective time-management, an innovative spirit, and the ability and desire to work both independently and collaboratively in a multidisciplinary, fast-paced, team-oriented environment are essential for the position.
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
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
- Some occasional travel to other Pfizer sites is possible. Overtime, off shift coverage, or holiday coverage, though rare, may be required.
ADDITIONAL OFFER DETAILS
Additional Location Information: St. Louis, MO
Eligible for Employee Referral Bonus: Yes
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EEO & Employment Eligibility
Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.
N (Other) (United States of America)
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