Location
Bothell, WA | United States
Job description
Why 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 As part of the Quality Control (QC) Testing team you are dedicated to supporting the release and stability testing of both our commercial and clinical stage programs. You will be responsible for performing the routine and non-routine testing and review with advanced proficiency and general QC laboratory work for the in-process support, release and/or stability of clinical development and/or commercial products in a GMP testing environment.
How You Will Achieve It - Routine review of plate-based bioassay and binding methods for stability and release assays
- Plate-based assay testing within the QC laboratory
- Authoring and owning deviations, CAPAs and Change Controls
- Revise and/or author standard operating procedures
- Occasional participation in qualification and validation of test methods
- Work closely within the QC organization as well as on a select number of cross-functional teams to ensure successful completion of group objectives
- Work with our LIMS system to support the QC testing group
- Applying the principles of good manufacturing practices (GMP) on a daily basis
- Identifying and participating continuous improvement projects
- Supporting special projects on analytical and instrument problem solving
- Serving as SME for Test Methods or other areas of expertise
QUALIFICATIONS Must-Have - Bachelor's degree in a relevant field
- 5+ years of experience in pharmaceutical/biopharmaceutical industry.
- 3+ years of experience working in a GMP laboratory
- Strong technical skills and in-depth understanding of plate-based assays, including cell-based bioassays and ELISAs
- Experience in GMP data review
- Highly organized with an attention to detail
- Strong knowledge of GMP compliance
- Strong technical writing and communication skills
- Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, etc.)
- Strong trouble troubleshooting skills
- Strong understanding of the listed equipment
- Strong data interpretation/analytical skills
- Experience authoring or revising Standard Operating Procedures
Nice-To-Have - Participation in Regulatory Inspections
- Proficient with Molecular Devices SoftMax Pro software
- Experience with a laboratory information management system (LIMS)
PHYSICAL/MENTAL REQUIREMENTS Job will include standing, walking, sitting and repetitive work with your hands. Occasional lifting may be required.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS None
Other Job Details: - Last day to Apply: March 12, 2024.
- Eligible for Relocation Assistance: NO
- Work Location Assignment:On Premise
The salary for this position ranges from $31.75 to $52.91 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.S. Benefits | (uscandidates.mypfizerbenefits.com). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided applies only to the United States - Washington - Bothell location.
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.
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