QA Specialist II

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 operations or laboratory support, 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 Pfizer’s clinical and commercial batches of drugs. 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 manufacturing and packaging of products. You will approve investigations and change control activities to ensure compliance with configuration management policies.

As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative team environment for your colleagues.

It is your hard work and commitment that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It

You will demonstrate sufficient depth of knowledge within your own work area in order to perform hands-on routine QA tasks. This role supports operations or laboratory including batch record, investigation, document review, and disposition activities. You will resolve routine quality issues related to product manufacture and testing with guidance/coaching. You will also be involved with project work as needed.

• Provides ongoing site-based operations or laboratory support for both start up and ongoing product manufacturing.

• Competently reviews batch records, deviations, and analytical investigations. (Cal OOTs, RAAC, CIS and Events)

• Exercises judgment in resolving quality issues and make batch disposition decisions.

• Reviews and approves documents with quality mindset.

• Uses established QA procedures and methodologies to propose solutions for straight forward problems with guidance and coaching.

• Makes decisions that require knowledge of quality systems.

• Represents QA on various teams; presents as QA-on-the-floor on a fixed weekly schedule.

• Reviews executed batch documentation for technical content within own subject area and reference to applicable GMPs and regulatory expectations, make value-added comments.

• Manages own workload with oversight by manager/peer.

• Represents their quality records with Board of Health inspectors, with support of management, as needed.

• Maintains inspection readiness and supports internal/external audits as needed.

QualificationsMust-Have

• Bachelor's Degree with 2+ years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required OR High School Diploma or Equivalent with 6 years of experience in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required OR Master's Degree with 1+ years of experience in in GMP Pharmaceutical or Medical Device Manufacturing environment or relevant regulatory experience (i.e. Board of Health) required.
• Sound knowledge of current Good Manufacturing Practices
• Ability to work in a team environment within own team and interdepartmental teams
• Effective written and oral communication skills

Nice-to-Have

• Field of study in Biology, Chemistry, Engineering, or related Technical Physical Science preferred
• Experience of writing and managing deviations

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

Position is first shift Monday through Friday.  Some occasional off hour (night/weekend/holiday) support may be required to support staff and operations.

Other Job Details:

• Eligible for Relocation Assistance: NO

#LI-PFE  

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.

Quality Assurance and Control