Quality Compliance Specialist

Biopharma Careers; Rocky Mount (NC); On-site; USD 69,000 - 114,000; Full time

Benefits offered by this job

401(k) with Pfizer Matching Contrib

Paid vacation and holidays

Medical, dental and vision coverage

Job summary

Pfizer is seeking a dedicated team member for aseptic manufacturing oversight in a 6am-6pm, 2/2/3 schedule, on-site in the United States. Responsibilities include real-time quality oversight, process simulations, and ensuring cGMP compliance to support patient access to medicines.

Requirements include a technical degree or equivalent experience, shop-floor aseptic manufacturing experience, and strong communication and problem-solving skills.

Qualifications

• Bachelor's in technical/science/engineering preferred with 0+ years experience; OR associate degree with 4 years experience; OR high school diploma and 6 years relevant experience.
• Shop floor experience in aseptic manufacturing environment required.
• Strong oral and written communication, presentation and interpersonal skills.
• Thorough knowledge of GMPs and ability to manage multiple projects.

Responsibilities

• Maintain working knowledge of cGMPs and regulatory/compliance concerns related to aseptic manufacturing.
• Support aseptic process simulations (media fills), smoke studies, and hypercare for new aseptic processes.
• Provide quality oversight during execution and recovery of planned/unplanned events (OARs, EDRs, Power Interruptions).
• Maintain Inspection Readiness Walkthroughs and ensure regulatory compliance.
• Drive continuous improvement via CI projects.

Skills

Aseptic manufacturing

GMP awareness

Communication skills

Multitasking

Education

Bachelor's degree in technical/science/engineering

Associate degree + 4 years experience

High school diploma + 6 years experience

Tools

None

Job description

Use Your Power for Purpose

Our breakthroughs would not make it to the hands of patients without our dedicated and agile pharmaceutical manufacturing team. We rely on members who understand the importance and impact of their role in Pfizer's mission. Patients need colleagues like you who take pride in their work and continuously strive to improve outcomes. Your efforts ensure that patients and physicians have the medicines they need when they need them. The significance of your role cannot be overstated, as you help bridge the gap between innovation and patient care. By being part of this team, you contribute to making life-saving treatments accessible, embodying the essence of our mission.

What You Will Achieve

• Enforcing best aseptic practices/techniques within the Aseptic or Terminally Sterilized manufacturing areas per the Aseptic Observation Program
• Providing real-time quality oversight during aseptic process simulations.
• Providing real-time quality oversight following planned and unplanned activities.
• Providing GMP walk throughs ensuring regulatory compliance.
• Providing real-time quality oversight during environmental control deviations.

How You Will Achieve It

• Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to aseptic manufacturing.
• Provide support to aseptic process simulations (media fills), smoke studies, and hypercare for new aseptic processes when implemented.
• Provide quality oversight and approvals during the execution and recovery of planned and unplanned events (OARs, EDRs, Power Interruptions).
• Maintain a compliant state (Inspection Readiness Walkthroughs)
• Enforcing best aseptic practices/techniques within the Aseptic or Terminally Sterilized manufacturing areas per the Aseptic Observation Program
• Meet Aseptic Observation Program Monthly/Annual required metrics
• Drive continuous improvement through implementation of continuous improvement projects.

Qualifications

Must-Have

• Applicant must have a bachelor's degree, in technical, science or engineering preferred, with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience
• Must have shop floor experience working in an aseptic manufacturing facility.
• Requires strong oral, written, communication, presentation and interpersonal skills.
• Requires thorough knowledge of GMP’s and ability to handle multiple projects.

Nice-to-Have

• Pharmaceutical manufacturing experience
• Experience working on Isolator/RABs Aseptic manufacturing.

PHYSICAL/MENTAL REQUIREMENTS

• Must be able to function under a stressful situation while being able to remain focused at the necessary requirements.
• Must be able to appropriately identify and elevate issues on a timely basis.
• Must be able to provide coaching and constructive feedback to operators.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Position is 6 am - 6 pm on a 2/2/3 schedule (Two on/Two off/three on)
• Must be able to work on weekend, off shifts and holiday as business demands.
• Work Location Assignment: On Premise

The annual base salary for this position ranges from $68,600.00 to $114,300.00. In addition, this position is eligible for participation in Pfizer’s Global Performance Plan with a bonus target of 7.5% 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.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email [e-mail] . This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers .

Manufacturing