Quality Control Associate Scientist

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.

You will be a member of Pfizer’s dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs.

This position is a 9 month secondment focused on Microbiological assays (e.g. bioburden, viable count method (serial dilution), sterility, microbial identification, culture purity, media certification is preferred). Analyst would be a Laboratory Analyst responsible for ensuring routine testing is completed, within the required time frame. Other responsibilities could include SOP revisions, qualification/validation support, leading/participating in projects.

The individual should be considered able to demonstrate the following:

It is your dedication and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

• Acting safely, knows and follows all EH&S safety requirements for site and QC laboratories; leads safety initiatives and encourages others to act safely

• Excellent effective written and verbal communication and interpersonal skills; established relationships within business lines
• Applies discipline’s principles, appropriate procedures, and leadership skills to action plan and contribute to executing toward team/project goals
• Ability to receive feedback from management and other colleagues, takes accountability for actions and personal development
• Consistent correctness and accuracy in tasks, activities, decisions, and documentation; detail oriented behavior
• Good judgment and correct decision making based on Pfizer procedures, policy and standards; quality systems knowledge; technical experience; and industry guidance / regulatory authority regulations; decision impact awareness on future quality and compliance as well as impact on own work group, department, and network
• Proactively identifies, takes remedial action, and/or seeks advice when a personal, project, or team goal/deliverable is off schedule
• Delivery on high business impact projects/activities/changes
• Capability of detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes
• Performs tasks associated with maintaining cGMP compliant Quality Control and Stability laboratories.
• Performs testing including, but not limited to clinical and/or commercial product, raw materials, validation, stability, and EM samples.
• Analyzes and interprets results, makes decisions regarding the accuracy, completeness and compliance; performs data trending
• Responsible for appropriate creation of GMP documentation (test results and records, validation protocols/reports, method transfer protocols/reports, test methods, equipment records, process transfer activities, etc.) and ensuring adherence to regulatory agency requirements, ICH guidelines, Pfizer standards, policies, and values.
• Responsible for detailing requirements for LIMS builds and/or building and testing new LIMS builds and LIMS Master Data changes.
• Responsible for reporting issues to management and participating in issue resolution (such as reporting OOS results and participating in associated laboratory investigations, reporting instrument issues and assisting with troubleshooting, etc.)
• Responsible for contributing to and/or handle laboratory investigations for events and OOS results.
• Responsible for assessing existing situations and suggesting continuous improvements to increase compliance and innovation.
• Perform tasks associated with maintaining Good Manufacturing Practices {also cGMP} compliant Quality Control and Stability laboratories.
• Act safely and follow Environment, Health and Safety requirements for site and QC laboratories.
• Apply existing techniques and procedures, with recommendations, and implement modifications for improved efficiency.
• Write Standard Operating Procedures (SOPs), technical reports, project plans etc. independently.
• Contribute to the completion of team objectives and assigned project milestones.
• Exercise and build basic team effectiveness skills, such as commitment, feedback and consensus management, within the work group.

• Applicant must have six years of relevant experience; OR an Associate's degree with four years of experience; OR a Bachelor's degree with 0-2 years of experience.
• Demonstrated experience in manufacturing, quality or engineering experience in the biotech or pharmaceutical industry
• Aptitude for good decision making based on procedures, guidance, and experience
• Excellent oral, written and interpersonal communication skills
• Knowledge of Microsoft Office applications, specifically Word and Excel

• Experience with Microbiology testing

PHYSICAL/MENTAL REQUIREMENTS

Ability to lift 30 lbs, stand for 2 to 3 hours at a time, sit for 2 to 3 hours at a time, walk long distances and bend to obtain items from lower shelving/cabinets

Intellectual capability to perform data analysis.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Work schedule can include weekdays and/or weekend days with first, second, and/or third shift hours as appropriate for assigned tasks/activities.

Work Location Assignment:On Premise

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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.