Environmental Monitoring Process Specialist (Afternoon shift) at Pfizer in rochester, Michigan

Job Description:

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 and control team. You will be responsible for activities involved in developing and maintaining quality programs, processes and procedures that ensure compliance with established standards and agency guidelines. Your contribution in quality risk management will help us in commitments tracking, interpreting policies, manage site complaints and work directly with operating entities to provide process analyses oversight.

 

Thanks to you, we will be prepared for all upcoming audits and inspections. You will be relied on to ensure that the quality assurance programs and policies are maintained and modified regularly. You will make sure that there are uniform standards worldwide and best practice sharing, which will help in fostering the achievement of company's mission globally.

 

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 teaming 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

 

• Recognize and anticipate the Laboratory's needs, and coordinate activities required from Quality Control (QC) in the transfer of products and perform product quality review.
• Prepare, review and approve deviation reports and change controls.
• Provide input to management on utilization, rates, and expenses.
• Provide technical support and training on new testing, systems and techniques.
• Perform water analysis and tests, such as Microbial Limit Test, Sterility tests, etc.
• Perform local release of imported products, in compliance with the applicable local regulations and local procedures, prior to distribution/sale within country.
• Maintain dehydrated and prepared media stocks, master Cultures Isolates and prepare Cryo vials.
• Review testing equipment and ensure electronic systems work properly, manage validation of new/existing equipment and perform calibration of all the instruments.
• Contribute to the completion of complex projects, manage own time to meet agreed targets and develop plans for work activities on own projects within a team.
• Become qualified on aseptic gowning and participate in a successful media filling operation.
• Perform all routine weekly/monthly sampling activities at the site including viable, non-viable, water, ISO and batch process environmental monitoring.

 

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.
• Demonstrated working knowledge and understanding of laboratory procedures, sample processing / analysis, and lab calculations
• Working knowledge of contemporary analytical techniques
• Knowledge of Good Manufacturing Practices {also cGMP}, validation principles, audit techniques, and working knowledge of statistics
• Effective communication skills, both verbal and written

 

Nice-to-Have

 

• Knowledge of drug/device combination product requirements
• Environmental monitoring experience in the pharmaceutical industry

 

PHYSICAL/MENTAL REQUIREMENTS

 

• Must be able to lift a minimum of 30lbs
• The position will require lifting, bending, and standing for periods of time, use of ladders and working within controlled environments.

 

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

 

• Must not have Penicillin allergy.
• Minimal travel for training/seminars.
• Must be aseptic gowning qualified to perform environmental monitoring activities

 

Work Location Assignment: On Premise

 

Last Day to Apply: November 18,2024

 

Relocation support available

 

The annual base salary for this position ranges from $64,600.00 to $107,600.00. 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.

 

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.

 

Quality Assurance and Control

 

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