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 are flexible, innovative, and customer oriented. Whether you are involved in the development, maintenance, compliance, or analysis through research programs, your contribution will directly impact patients.What You Will Achieve
This Senior Chemist role represents the Rapid Turn Lab unit or the entire lab organization on high-complexity projects and project teams both within and outside of Quality Operations. The Senior Chemist will perform LIR supervisor duties for Atypical, OOS, Questionable, and Invalidated Data occurrences and will cover data integrity responsibilities.
The Senior Chemist represents and/or leads the lab unit or the entire lab organization on high-complexity projects and project teams both within and outside of Quality Operations, including but not limited to data integrity initiatives, and PQS compliance requirements, and continuous improvement projects.
This role provides leadership and technical expertise to assist the laboratory with troubleshooting, investigations, computer validation, and instrument qualifications. The Senior Chemist may be involved in the second checking of data and will perform assays as needed.
The Senior Chemist will be directly involved in the implementation of system conversions (i.e. Empower 3, gLIMS, and Batch Tracker), they may also assist with method improvements as well as other infrastructure support functions.
This role has the responsibility of serving as a Management Designee and will have limited input into the OTE colleague performance assessment process. The Senior Chemist may defend QC Laboratory Quality Systems during audits and inspections.How You Will Achieve It
• Leads and documents laboratory investigations for procedural deviations, atypical, OOS, questionable, and invalidated data occurrences.
• Assures adherence to data integrity initiatives.
• As a Subject Matter Expert (SME), represent the lab unit or the entire lab organization on high-complexity projects and project teams both within and outside of QO. Leads medium or high complexity project teams within QO tasked with improving laboratory or other quality systems.
• Determines scheduling priorities and workload distribution to ensure customer needs are met with minimal guidance from QO Lab leadership.
• Proactively identifies opportunities for improvements to procedures/processes and actively drives those improvements.
• Manages the balance of daily workload and customer priorities within the team with minimal guidance from QO Leadership.
• Performs data quality inspection through Quality audits and 2nd check of laboratory data packets
• Performs analytical assays during times of need.
• Demonstrates technical mastery of chromatography.
• Applies knowledge of advanced techniques and procedures with recommendations and implementation of new or modified procedures or instrumentation for improved lab efficiency.
• Trains others in the theory and practice of both laboratory techniques and quality systems including investigations, instrument qualifications, etc.
• Independently write SOPs, technical reports, project plans, instrument qualifications, etc.
• Serves as management designee and will have limited input into the OTE colleague performance assessment process.QualificationsMust-Have
Applicant must have a High School Diploma (or equivalent) and 8 years of relevant experience OR an associate's degree with 6 years of experience OR bachelor with at least 3 years of experience OR master's with more than 1 year of experience.
Ability to receive feedback and takes accountability for actions and personal development
Excellent effective written and verbal communication and interpersonal skills
Basic computer skills, such as data entry, with a high level of attention to detail, are also required
- Laboratory and Quality Investigation experience
- Prior experience with instrument qualification
Laboratory and office work requires walking, standing, and sitting throughout a shift. Lifting of items less than 25 kg. Must have the ability to maintain mental focus on multiple complex challenges throughout a shift.
NON-STANDARD WORK SCHEDULE, TRAVEL, OR ENVIRONMENT REQUIREMENTS
There is no routine travel.Normal work hours are Monday - Friday 7 am - 3:30 pm. Work outside of core work hours will occasionally be required to support projects, investigations, etc. as defined by business needs.
Relocation support available
Work Location Assignment:On-Premise
Last date to apply - 8/18/2022
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.
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