QA Specialist III (2nd shift)

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 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 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.
• 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.
• Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs.

Qualifications
Must-Have

• Applicant must have a bachelor's degree with at least 2 years of experience;
• OR a master's degree with 0+ years of experience;
• OR an associate's degree with 6 years of experience;
• OR a high schooldiploma (or equivalent) and 8 years of relevant experience
• GMP manufacturing/quality experience
• Current Good Manufacturing Practices (cGMP) experience with compliance issues resulting from cGMP deviations or product defects, regulations as related to vendor management programs and other industry quality systems and processes
• Ability to work in a fast-paced environment and be able and willing to juggle priorities as required.
• 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 experience operating within quality enterprise systems

Nice-to-Have

• Experience in Quality Systems in pharmaceutical, medical device, or combination product industry
• Previous experience in QA strongly preferred.
• Previous experience in QC, Manufacturing and/or Engineering preferred.
• Skilled at the use of Enterprise systems including, but not limited to site Quality Tracking System (QTS), Veeva Vault, Laboratory Information Management System (LIMS), SAP and Pfizer document repositories.

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to be present at the Andover site routinely as required.

• Must be able 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 2PM - 2AM, 12-hour rotating 3/2/2 schedule
• Work Location Assignment: On Premise

Work Location Assignment: On Premise
The annual base salary for this position ranges from $80,300.00 to $133,900.00. In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 10.0% of the base salary. 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