Associate, QA Validation Job at Pfizer
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
This role is responsible for providing quality assurance support to GMP facilities and equipment for our Pharmaceutical Sciences manufacturing and testing operations based at the Pfizer Andover, MA Site. This will include supporting utility, manufacturing (cell bank, drug substance and drug product), laboratory and related computer systems to enable the disposition of biologic clinical trial materials. This role is responsible for the review of documentation related to validation, maintenance, and calibration activities. This role will have responsibility to review procedures, change controls, Investigations, and commitments. The Associate QA is part of the Pfizer Pharmaceutical Sciences Operations Quality (PSOQ) Team and will partner closely with quality, manufacturing, and laboratory lines. This is a Hybrid role where On-site support is required but will have some flexibility to work remotely. This role requires minimal understanding of the regulations pertaining to facilities and equipment used in GMP manufacturing and testing. Additionally, this role will require the candidate to multi-task and independently manage their work while delivering and positively interacting with our customers. On top of current experience, the candidate shall possess the capabilities to learn and expand their knowledge moving forward. Experience in the use or quality support of digital systems (e.g. manufacturing control systems, Enterprise Asset Management Systems [EAMS], investigation and change control systems) is helpful. Experience and understanding of data integrity (DI) and electronic records and electronic signatures (ERES) as it pertains to computerized systems and equipment is helpful.
How You Will Achieve It
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Provide Quality Assurance support for the Pharmaceutical Sciences validation program at the Andover, MA Pfizer site including utility, manufacturing, laboratory, and computer systems.
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Role includes less complex validation documentation review and approval including specifications, protocols, testing documents, vendor assessments, summary reports, data integrity assessments as well as any supporting documentation associated with maintaining validated state.
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Provide QA support to the Pharmaceutical Sciences requalification program for all equipment and instrumentation used in Pharmaceutical Sciences cell bank, drug substance, and drug product manufacturing facilities as well as analytical and microbiological laboratories at the Andover Site.
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Review and approve less complex change controls and investigations. Review and approve commitments and procedures.
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Provide quality support to the calibration of equipment including review of Out-Of-Tolerances.
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Provide QA support to the Electronic Asset Management System (EAMS) including work order review and approval, as needed.
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Participate in the onboarding of new equipment, instruments, and systems.
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Support and understand Data Integrity principles (ALCOA) as well as Electronic Record and Electronic Signatures (ERES) in support of our digital systems.
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Represents Quality Assurance by sitting on or providing validation-related support to local or global project teams when required.
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Provide quality support to qualifying service providers (e.g. validation, calibration, maintenance).
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Support the site relative to a constant state of inspection readiness. Participate in audits relative to this role, as needed.
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May participate in quality risk management activities.
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May participate or lead less-complex projects, limited duration teams, and local or global initiatives such as continuous improvement teams for Quality Assurance.
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Ability to resolve less-complex issues within specific role and escalate non-routine issues appropriately.
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Able to seek out and assess internal and external compliance with applicable regulations.
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Ability to present to peers/management locally and virtually inclusive of communicating with other Pfizer Sites.
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As a Pfizer colleague, responsible for knowing, understanding, and acting in accordance with Pfizer’s values.
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The successful candidate will possess strong interpersonal, teamwork, and collaboration skills.
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Contributes to PSOQ management team initiatives and objectives.
Qualifications
Must-Have
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Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0+ years of experience.
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2+ years of relevant experience within a GMP environment required.
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Team player with strong interpersonal, organizational, and communications skills are a must.
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Candidate must be self-motivated, engaged and able to perform moderately complex tasks independently.
Nice-to-Have
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Bachelor's Degree in ascientific or engineering discipline required.
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Some Experience working in biopharma GMP manufacturing and/or laboratory operations is helpful.
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Mechanical or Chemical Engineering background is helpful.
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Awareness of FDA and international regulatory requirements as related to GMP facilities and equipment is desirable.
PHYSICAL/MENTAL REQUIREMENTS
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Mental agility to handle a large quantity and broad scope of different types of quality assurance work.
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Ability to independently problem solve and make recommendations for solutions.
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Role is primarily office setting. Traveling outside between buildings on Andover Pfizer campus is required.
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Role includes leading and/or participating in virtual and in-person meetings and frequent use of Microsoft applications (e.g. MS Teams).
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
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Role is a standard daytime 40-hour work week.
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This is a flexible role, on premise work will be required but have flexibility work remotely as well.
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Adherence to Pfizer safety practices is a must.
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It is not anticipated that this role will require business travel but it would be minimal if needed.
OTHER
First Shift
Last Day of Posting May 9, 2023
Work Location Assignment: Hybrid
Work Location Assignment: Hybrid
Relocation assistance may be available based on business needs and/or eligibility.
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.
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