Quality Compliance Specialist
Quality Compliance Specialist
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$ 66500 - 110900
1 Vacancy
Job Description
Why Patients Need You
Our breakthroughs would not make it to the hands of patients without our pharmaceutical manufacturing team. We rely on a team of dedicated and agile members who understand the importance and impact of their role in Pfizers mission. Patients need colleagues like you who take pride in their work and always look to improve outcomes. You will help to ensure that patients and physicians have the medicines they need when they need them.
What You Will Achieve
In the Aseptic Manufacturing team you will be accountable for the oversight or operational activities involved in the aseptic cleaning and/or other chemical cleaning involved in Pfizers manufacturing plants and/or distribution centers. Your work will involve determining manufacturing methods procedures and tooling requirements designing tools and planning production sequences.
As an associate your focus on the job will contribute in achieving project tasks and goals. The primary function of the Quality Compliance Specialist is to monitor teach and enforce best and proper practices/techniques within the R1/R2/R3 SVP filling manufacturing areas. The candidate will perform routine monitoring duties of the SVP operation to ensure compliance in alignment with site SOPs and regulations. In addition the candidate must be able to train new and existing colleagues on aseptic principles and coach them on expectation for sterile manufacturing.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
Perform necessary assessments of Aseptic or Terminal Sterilized SVP Filling operation and identify process improvement needs.
Performs the observation sessions to accumulates key metrics for presentation to Management teams.
Perform observation sessions of sanitation aseptic techniques clean room behaviors equipment cleaning/loading activities and gowning.
Responsible for maintaining working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.
Support investigations and implement CAPAs as needed.
Generate change controls for procedure updates as needed.
Provide support to aseptic process simulations (media fills) smoke studies and hypercare for new aseptic processes when implemented.
Provides support to other investigations on site to help to identify root cause(s).
Qualifications
Must-Have
Applicant must have a High School Diploma (or Equivalent) and 6 years of relevant experience OR an associates degree with 4 years of experience OR a bachelors degree with 0 years of experience.
Knowledge/experience in aseptic technique; 1 years knowledge/experience in aseptic.
Strong oral written communication presentation and interpersonal skills.
Thorough knowledge of GMP and ability to handle multiple projects.
Basic Excel and other Microsoft skills.
Nice-to-Have
3 years experience in aseptic manufacturing; on the floor experience.
Demonstrated strong leadership and people management skills.
Knowledge of change control process (i.e. document writing and editing).
PHYSICAL/MENTAL REQUIREMENTS
Must be able to function under a stressful situation while being able to remain focused at the necessary requirements. In addition must be able to appropriately identify and escalate issues on a timely basis.
Must be able to consistently aseptic gown.
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.
Relocation support available
Work Location Assignment:On Premise
OTHER JOB DETAILS
Last Date to Apply for Job: July 9th 2025
The annual base salary for this position ranges from $66500.00 to $110900.00. In addition this position is eligible for participation in Pfizers 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 lifes 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 (). 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.
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 providers 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
