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