Why Patients Need YouEverything 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 AchievePerforms microbiological testing such as final sterility, endotoxin, bioburden, TAMC, growth promotion, and MLT on raw materials, excipients, Active Pharmaceutical Ingredients for in-process and final product, environmental monitoring samples, process & cleaning validation samples using standardized and validated methods per company, compendia and regulatory requirements.Results are compared with specifications and documented. Incumbent has mastered most or all of fundamental technical and quality concepts. In addition, writes protocols, reports, and investigations associated with the laboratory and to support method validation activities.How You Will Achieve It
Accountable for the accuracy and validity of testing results. Performs mathematical calculations, interprets results, and records observations. May utilize Laboratory Information Management Systems. Develops problem solving skills.
Takes initiative; seeks out additional assignments, etc.
Maintains all related records, prepares and records media, buffers and reagents, etc., and maintains work area in a neat and orderly manner. May assist in coordinating the testing activities of the group.
Learns to analyze and interpret project/study/investigation results and findings. Determines next steps under guidance of Manager and in compliance with applicable regulations; carries out technical and administrative duties as assigned.
Responsible to ensure timely analyses of biopharmaceutical products during manufacturing, release testing and stability monitoring. This will be achieved by efficiently managing the testing schedule based on laboratory and operational needs.
Organization and monitoring of work in the associated laboratories and communication with functions outside Quality unit.
Procurement ordering for Media and consumables in laboratories.
Support laboratory metrics and drive continuous improvement of cGMP in laboratory.
Evaluation of results and resulting trends as needed.
Participation in resolving laboratory investigation and in activities related to change control process as needed.
Review of relevant documentation within the laboratory.
Support the creation of laboratory reports, method procedures, validation protocols and validation reports and instructions.
Monitoring and implementation of GMP and other relevant regulatory requirements for biopharmaceutical products as it pertains to the laboratory.
Responsible to maintain data integrity principles in everyday laboratory operations.
Performing other jobs and tasks as needed in accordance with professional qualifications and experience, such as completing analysis of samples within the laboratory
QualificationsMust-Have
Bachelor's degree in Chemistry, Biology, Microbiology or relevant scientific field.
5 - 8+ years of laboratory experience.
2+ years of work experience in a regulated industry.
Experience in coordinating quality operational activities.
Demonstrated management experience, either through direct people leadership or significant project management experience, including:
Strategic Planning
Communication and Presentation Skills
Decision making
Coaching/development of others
Willingness to establish networks (in site, across OpU / network)
A team player with strong interpersonal, organizational, and communications skills are a must. Additionally, the candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.
Nice-to-Have
Biopharma/pharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes and Quality Systems preferred.
Experienced practitioner of DMAIC principles.
Knowledge of GMP regulations/guidances (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry
Knowledge of pharmaceutical QC quality systems
PHYSICAL/MENTAL REQUIREMENTS
This position will spend significant time in a laboratory environment and must be able to wear all required PPE.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
May require support for site as needed beyond core business hours.
Little to no travel required
Work Location Assignment: On PremiseThe annual base salary for this position ranges from $74 900,00 to $124 800,00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 7,5% of the base salary. 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 does not apply to Tampa, FL or any location outside of the United States.Relocation assistance may be available based on business needs and/or eligibility.Sunshine ActPfizer 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 EligibilityPfizer 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.Quality Assurance and Control#LI-PFE
