QA Senior Specialist - 2nd Shift - Pfizer
Andover, MA
About the Job
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
You will be a member of Pfizer’s dedicated and highly effective quality assurance team. You will evaluate and review various documentation related Pfizer’s commercial batches. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
You will be able to take a leadership role to facilitate quality decisions.
It is your problem-solving skills that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Represents QA on site teams with minimal supervision.
Performs all tasks related QA on the Floor within the suite as appropriate, and collaborates with other members of QA, Operations, etc to maintain quality support as well as inspection readiness.
Conduct On floor QA review of executed batch records and Logbooks to assure compliance with Site SOPs, Regulatory standards and filings.
Anticipate issues and escalate to appropriate management attention immediately.
Exercises judgment in resolving moderate to complex quality issues.
Plans and executes work independently and consults with supervisor as needed.
Leads quality discussion and uses breadth of knowledge to contribute to strategies and decisions.
Review and approval of complex deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact while providing sound quality assurance judgment to ensure product quality.
Active participant/lead for M1s/M2s; promoting and leading adherence to the DMAIC process. Champion for implementation of sound preventative actions, leveraging the Pfizer Human Performance tools.
Collaborate/independently engage with a wide range of co-workers, customers and management within PGS to gather the input and background knowledge needed to complete assignments.
Reviews and approves protocols, reports and batch records, and authors, reviews and approves SOPs as appropriate for both Operations and Quality.
Review and approval of change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.
Coach/mentor/train other QA colleagues that will be hired for operational readiness and routine manufacturing support
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 10 years of relevant experience OR an Associate's degree with 8 years of experience OR a Bachelor's degree with at least 5 years of experience OR Master's Degree with more than 3 years of experience, OR a PhD with 0+ years of experience
Experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required
Current Good Manufacturing Practices experience with compliance issues resulting from cGMP deviations or product defects, regulations and other industry quality systems and processes
Proven experience with quality decision making under cGMP conditions
Proactive approach and strong critical thinking skills
Strong collaboration, relationship management, and interpersonal skills
Excellent written and verbal communication
Advanced computer skills in MS Office applications and good knowledge of enterprise systems, such as, Veeva Vault (EQMS) or LIMS
Nice-to-Have
Previous Quality Assurance experience strongly preferred.
Previous experience in Quality Control, Manufacturing and/or Engineering preferred.
Experience in Quality Systems in pharmaceutical, medical device, or combination product industry.
Physical/Mental Requirements
Ability to gown into cGMP Manufacturing areas and adhere to governing gowning procedures as appropriate.
Non-Standard Work Schedule, Travel, or Environment Requirements
This role is second shift, 12-hour rotating 3/2/2 schedule
Other job details
Last day to apply: September 24th, 2024
Eligible for Relocation Package – NO
Work Location Assignment: On Premise
The annual base salary for this position ranges from $93,500.00 to $155,900.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 12.5% of the base salary and eligibility to participate in our share based long term incentive program. 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 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. This position requires permanent work authorization in the United States.
Quality Assurance and Control
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