Pfizer

Quality Compliance Specialist

Pfizer$68K — $114K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in technical, science, or engineering preferred OR associate's degree with 4 years of experience OR high school diploma and 6 years of relevant experience.
  • Experience in an aseptic manufacturing environment is essential.
  • Strong oral and written communication, presentation, and interpersonal skills are required.
  • Thorough understanding of cGMPs and ability to manage multiple projects effectively.

Responsibilities

  • Enforce best aseptic practices within manufacturing areas according to the Aseptic Observation Program.
  • Provide real-time quality oversight during aseptic process simulations and following planned or unplanned activities.
  • Conduct GMP walkthroughs to ensure regulatory compliance.
  • Oversee quality during environmental control deviations and planned recovery events.
  • Drive continuous improvement through implementation of relevant projects.

Benefits

  • Comprehensive health benefits including medical, dental, and vision coverage.
  • Paid vacation, holiday, and personal days.
  • Paid caregiver and medical leave support.
  • 401(k) plan with company matching contributions and additional retirement savings contributions.
Full Job Description

What You Will Achieve

The primary function of the Quality Compliance Specialist is to provide quality oversight in manufacturing areas by :

  • 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 schooldiploma (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 GMP92s 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 escalate 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 Pfizer92s 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 life92s 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 91 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.

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

Manufacturing

About Pfizer

Hospira, Inc. is the provider of injectable drugs and infusion technologies. Through its broad, integrated portfolio, Hospira is uniquely positioned to Advance Wellness™ by improving patient and caregiver safety while reducing healthcare costs. The company is headquartered in Lake Forest, Ill., and has approximately 16,000 employees.

Pfizer Careers

Joining Pfizer’s global team offers more than just job opportunities; it’s a chance to be a part of a company that leads with science and innovates for better health. As a leading biopharmaceutical company, Pfizer is at the forefront of transforming lives through innovation, leadership, and diversity. Work You’ll Do At Pfizer, you will collaborate with some of the brightest minds in the industry, engaging in work that enhances global health and saves lives. Our culture thrives on intellectual curiosity, professional growth, and inclusivity, making every day a learning opportunity. Here, your skills will be honed, your professional acumen will be expanded, and you will be part of a team that values the power of diverse insights to drive success. Pfizer’s Leadership and Growth Lead and innovate with Pfizer, where we value the growth of each employee. Our leadership is committed to providing employees with the training and resources needed to excel in their careers. Pfizer offers a variety of career paths, including roles in research, marketing, finance, technology, and more, each offering a unique blend of challenges and rewards. Internship and Employment Opportunities Start your career with Pfizer through our internship programs or dive straight into a full-time position. We are hiring individuals who are passionate about healthcare and who seek to make a difference in the world. Our internships provide invaluable industry experience, networking opportunities, and a potential pathway to full-time employment. Benefits and Culture Pfizer is dedicated to fostering a workplace where all employees feel valued and can achieve their full potential. We offer competitive benefits packages that support the health, well-being, and financial security of our employees and their families. At Pfizer, you’ll find a culture that encourages collaboration, innovation, and continuous learning. Join Our Team Explore the numerous job opportunities at Pfizer by searching open positions that match your skills and interests. We look for driven, curious, and innovative team players who are ready to advance their careers in a transformative company. Stay Connected Keep up to date with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work here. Personalize your subscription to receive job alerts, latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities that await at Pfizer. Interview and Resume Tips Prepare for your future with Pfizer by utilizing our resources for resume building and interview preparation. We provide guidance on how to effectively showcase your skills and experiences to align with the needs of a position at Pfizer. Our goal is to help you succeed in securing a role that suits your professional goals and personal growth aspirations. Pfizer: A Place Where You Can Make a Difference Every position at Pfizer contributes to our mission of making the world a healthier place. Whether through direct patient care, research innovation, or corporate roles that support our operations, your work will have global impact. Join us in our journey to change lives—explore Pfizer careers today.
Learn more about Pfizer
Size
79,000 employees
Market Cap
$285.9 billion
Industry
Net Income
$9.6 billion
Founded
1849
5 Year Trend
+9%
Revenue
$41.9 billion
NASDAQ

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