Environmental Monitoring Analyst I - 1St Shift

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 team member who is relied to have a good understanding of procedures, techniques, tools, materials and equipment. Your decision making will help you prioritize workflows based on the available resources. You will follow standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. You will contribute to the team's success by sharing your previously acquired knowledge.

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

• Manage own time, professional development and be accountable for own results.

• Interpret and evaluate data in terms of accuracy, precision, trends, and potential Good Manufacturing Practices {also cGMP} impact and recommends appropriate corrective action where necessary.

• Work effectively in a fast-paced, customer-oriented, team laboratory environment to analyze raw materials and packaging samples in support of the company's quality program in the chemistry laboratory.

• Complete training activities and maintains records, equipment, basic lab supplies, and re-agents in accordance with {Current} Good Manufacturing Practices {part of GxP} requirements.

• Participate in laboratory investigations as required.

• Prepare Quality Performance Review.

• Adhere to safe work practices, such as wearing appropriate personal protective equipment including lab coat, safety glasses, and gloves.

• Perform equipment verification and calibration in accordance to procedures.

• Maintain area and equipment in clean, safe, functional order.

• Perform environmental monitoring in a safe, compliant, and efficient. The job responsibilities include performing environmental monitoring in the Aseptic Manufacturing Environment in order to ensure that our products meet the highest standards of quality.

• Gain an understanding of cGMPs, GLPs EHS and site/ department policies and environmental monitoring concepts.

• Perform all routine weekly/monthly sampling activities at the site including viable, non-viable, water, ISO and batch process environmental monitoring.

• Enter and verify environmental monitoring data into various databases/computerized systems and review associated documentation in an accurate and in a timely manner.

• Author and review monthly/annual data reports.

• Ensure environmental monitoring supplies are ready and available within the Aseptic Processing Area (APA) and in the QC Laboratory. Support of production/manufacturing team members as business partners working in the APA.

• Become qualified on aseptic gowning and participate in a successful media filling operation.

• Consistently demonstrate proper documentation practices.

• Perform and document aseptic observations and coaching of Manufacturing Operators per the site aseptic practices program.

Work practices and processes will meet the following expectations:

• Must maintain and neat and tidy workspace.

• Consistently adheres to company, site and laboratory safety rules and immediately raises any safety observations, concerns or suggestions.

• Follow company, site and global procedures at all times adopting cGMP, cGDP practices.

• Follows management direction at all times.

• Able to function independently while asking questions without hesitation when needed or unsure.

• Accepts dynamic work sequences and schedule changes.

Planning, Communication, Teamwork, Initiative and Performance Expectations:

• Actively participates in daily and weekly planning discussions among teammates and Management (as needed) offering suggestions to improve RFT and Manufacturing Schedule support as needed.

• Consistently communicates work sequence status in a timely manner.

• Where work was not achieved, actively participates in discussions to identify opportunities for correction and improvement.

• Demonstrates engagement in helping to achieve QC Team, individual as well as site goals.

• When faced with roadblocks or issues, routinely offers suggestions for improvements.

• Maintains a positive influence on the QC Team, often going out of his/her way to support and assist teammates across different shifts as necessary.

Qualifications

Must-Have

• High School Diploma or GED.

• 2+ years' experience.

• Basic math and computer skills, such as data entry, along with a high level of attention to detail.

• Understanding of equipment, instrumentation, and computer applications.

• Willing to learn and development a career in the pharmaceutical manufacturing industry.

• High productivity and the ability to multi-task coupled with a low error rate.

• Ability to read, comprehend, and follow procedures.

• Good oral, written and interpersonal communication skills within a diverse team setting.

Nice-to-Have

• Strong documentation and communication skills.

• Strong Organizational skills and the ability multi-task across various projects and activities.

• Must have good written and verbal communication skills.

• Follow written and verbal instructions.

• Must be able to obtain and to maintain multiple technique proficiencies (as dictated by site ad business needs).

• Complete all training, written exams and certifications.

• Flexible to work on any shift temporarily as business need dictate. Some weekend work required.

• Experience in a GMP environment.

• Quality Control experience in a pharmaceutical industry.

Physical/Mental Requirements

• Job duties can be physically demanding. These duties include: moderate lifting, standing for long periods of time, sitting at a computer terminal and laboratory bench work.

• Candidate must be able to complete aseptic gowning training. Candidate will need to understand principles of scientific writing and design of experiments.

• This position is located in a penicillin facility. The candidates must not be allergic to penicillin.

Non-Standard Work Schedule, Travel or Environment Requirements

• Work Location Assignment: On Premise.

• This is a 1st shift position with core hours from 7:00 am to 3:30 pm (Monday through Friday).

• Unusual attendance and weekend work or travel may be required to support production activities.

Other job details

• Last day to apply: March 25, 2024.

• Relocation assistance: No.

The salary for this position ranges from $18.62 to $31.03 per hour. In addition, this position offers eligibility for overtime, weekend, holiday and other pay premiums depending on the work schedule and the Company's policies. 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 applies only to the United States

• Michigan

• Rochester location.

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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