QA Senior Specialist, 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 clinical and 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.
- Leads quality discussion and uses breadth of knowledge to contribute to strategies and decisions.
- Will be responsible for collaborating with both Quality Control and Operations to support startup of a new manufacturing facility. Influences quality strategy for all aspects of suite start up, demonstration runs, and routine manufacturing.
- Once the product is being routinely manufactured, position will make disposition decisions that may involve complex quality issues. Decisions may impact on disposition cycle and timelines.
- Acts as back-up for Suite GH Operational Readiness QA Lead in when necessary.
- Independently handle complex investigations in cross-functional work areas.
- 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.
- Anticipate issues and escalate to appropriate management attention immediately.
- Reviews and approves protocols and reports and batch records, and authors, reviews and approves SOPs as appropriate for both Operations and Quality Control.
- Review and approval of change controls for appropriateness, completeness and alignment with quality, validation and regulatory expectations.
- Reviews and approves routine to complex investigations, providing sound quality assurance judgment to ensure product quality.
- Exercises judgment in resolving moderate to complex quality issues.
- Plans and executes work independently and consults with supervisor as needed.
- Incumbent knows and applies technical and quality concepts, applicable guidelines of the FDA or other regulatory bodies and relevant SOPs. Seeks out regulatory guidance for new product introduction.
- Review and approval of deviations and resulting investigation reports, corrective actions and/or preventive actions for adequacy, logic and quality/validation/regulatory impact.
- 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.
- 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.
- Coach/mentor/train other QA colleagues that will be hired for operational readiness and routine manufacturing support
- Bachelor’s Degree in Biology, Chemistry, Engineering, or related Technical Physical Science required
- 7 – 10+ years of 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 as related to vendor management programs 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 Quality Tracking System Trackwise or LIMS
- 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.
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 – start time is flexible between 11am – 1pm.Sunshine ActPfizer 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 EligibilityPfizer 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