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
Ensures that quality control procedures adequately evaluate an organization's products. Determines if current methods and techniques result in meeting reliability standards or require modification. Devises testing plans, methods and equipment to assure reliability of product in conjunction with product design and specifications.
Accountable for 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 will master most or all 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
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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.
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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.
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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.
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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.
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Evaluation of results and resulting trends as needed.
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Participation in resolving laboratory investigation and in activities related to change control process as needed.
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Review of relevant documentation within the laboratory.
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Support the creation of laboratory reports, method procedures, validation protocols and validation reports and instructions.
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Monitoring and implementation of GMP and other relevant regulatory requirements for biopharmaceutical products as it pertains to the laboratory.
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Responsible to maintain data integrity principles in everyday laboratory operations.
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Performing other jobs and tasks as needed in accordance with professional qualifications and experience, such as completing analysis of samples within the laboratory.
Qualifications
Must-Have
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High School Diploma (or Equivalent) and 8 years of relevant experience.
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Associate's degree with 6 years of experience.
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Bachelor's degree with at least 3 years of experience.
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Master's degree with more than 1 year of experience.
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Knowledge of various microbial test methods.
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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
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Degree in Biology and Microbiology.
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5 - 8+ years of laboratory experience.
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2+ years of work experience in a regulated industry.
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Biopharma/pharma industry experience that includes a broad understanding of Biopharmaceutical Sciences processes and Quality Systems preferred.
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Experienced practitioner of DMAIC principles.
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Knowledge of GMP regulations/guidance (21 CFR Parts 11, 210 &211; EC Annex 15; ICH 7) as they pertain to the pharmaceutical/biopharmaceutical industry.
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Knowledge of pharmaceutical QC quality systems.
Physical/Mental requirements
Non-standard work schedule, travel or environment requirements
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May require support for site as needed beyond core business hours.
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Shift: 1st shift (8:00 am to 5:00 pm).
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Little to no travel required.
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Work Location Assignment: On Premise.
Other job details
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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.
Quality Assurance and Control
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