Address
Form of work
SalaryWhy Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
Supports daily Sample Management operations to ensure samples are available for QC to test (received from or sent to the correct internal and external locations) and ensure complete chain of custody is maintained in accordance with standard operating procedures (SOPs) in a cGMP compliant QC laboratory. This position is dedicated to one QC site but may provide backup to other QC sites.
How You Will Achieve It
- Perform routine Sample Management activities, including sterile sample aliquoting and proper storage and disposal of samples.
- Perform sample receipt and prepare outgoing shipments.
- Coordinate with external contract testing laboratories for sample submission and testing.
- Complete and review chain of custody documentation, temperature data, and LIMS entries.
- Archive chain of custody documents and other QC documentation as needed.
- Perform routine maintenance on Sample Management laboratory equipment, such as cleaning BSCs, refrigerators, and freezers.
- May create advanced testing templates in LIMS.
- May be subject matter expert for Sample Management in audits and regulatory agency inspections.
- Assist the LIMS team in system troubleshooting and process improvements.
- Perform periodic inventory of product samples and product reference materials.
- Maintain close communication and interaction with QC lab leads and manufacturing staff to ensure on-time distribution of samples.
- May set up elements in systems integrated with LIMS to auto-report stability data (e.g., Discoverant).
- May assist in equipment management including but not limited to reviewing equipment logbooks, reviewing tasks in maintenance management system, and coordinating with Facilities for scheduling maintenance and repairs.
- Apply the principles of good manufacturing practices (GMP) on a daily basis.
- Create and revise standard operating procedures (SOP’s), work instructions, and other documents as needed.
- Identify, participate in, and/or lead continuous improvement projects.
- Author and own deviations, CAPAs, and change controls as needed.
- Train other personnel.
- Maintain training to current standards and procedures on all assigned curriculums.
- Fully comply with company health and safety procedures and practices.
QUALIFICATIONS
Must-Have
- Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 2+ years of relevant experience)
- Be highly organized with an attention to detail
- Ability to keep order of multiple projects/tasks
Nice-To-Have
- Experience authoring and/or revising Standard Operating Procedures
- GMP experience
- Experience with a LIMS or other sample/inventory management system
PHYSICAL/MENTAL REQUIREMENTS
Job will include standing, walking, sitting, document review and ability to perform mathematical calculations and complex data analysis. Occasional lifting may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Evening, weekend, holidays and/or on-call work may be required.
Other Job Details:
- Last day to Apply: February 29, 2024.
- Eligible for Relocation Assistance: NO
- Work Location Assignment: On Premise
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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. This position requires permanent work authorization in the United States.
