Qo Technical Associate Iii - Aseptic Observations Technician

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
This position is for an observation specialist in the Kalamazoo QO Aseptic Plant Support team working on First Shift (6:00AM to 2:30PM ). Opportunity for schedule flexibility exists as the role supports observations of production on weekends and holidays. The role will conduct observations in the Grade A & Grade B areas of the facility.
Provides other Aseptic Plant Support coverage as business needs dictate.

• Works effectively in a fast-paced, patient focused, aseptic production environment to ensure adherence to procedures and qualification records.
• Independently performs observations of aseptic production activities and documents results.
• Provide feedback/coaching to peers in a manner that ensures a positive work environment. Input data into electronic systems for trending purposes and writes reports as needed.
• Participates in investigations as required. Independently reviews process qualification records and ensures production activities continuously align to the respective qualification records.
• Continue to provide input and feedback for program enhancements.
• Participate in Media fills and as applicable, conduct environmental monitoring support.
• Applies technical knowledge of microbiological principles, theories, concepts and Pfizer processes and industry practices/standards to their daily work.
• Works both independently and as part of a team.
• Operates within established HR policies and basic colleague relations guidelines.
• Contributes to the completion of specific team objectives and assigned project milestones.

How You Will Achieve It

• Manage own time, professional development and accountable for own results.
• Prioritize own workflow and assist in prioritizing the workflow of less-experienced colleagues.
• Responsible for maintaining laboratory compliance.
• 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.
• Perform, document, record check, and troubleshoot qualitative or quantitative assays on samples using techniques that vary from use of standard laboratory equipment to highly modern and automated instrumentation.
• Perform testing for semi-finished goods and finished goods testing, validation sample, and other testing in accordance with approved procedures and test methods and record the test results in timely manner.
• Investigate, analyze, problem solve, and communicate technical information to internal and external customers.
• Ensure all reagents and reference standards are valid and stored according to requirement.
• Comprehend and perform both routine and non-routine analyses from compendia and internal sources.
• Work effectively in a fast-paced, customer-oriented, team laboratory environment to analyze final drug products in the Drug Product Laboratory.
• Train and support less experienced analysts, working as a Certified Fellow Employee and mentor to aid in their development as analysts.

Qualifications
Must-Have
Education:

• High school diploma (or equivalent) plus 6 years of relative experience in quality or compliance.
• Associates degree in Chemistry, biology or related science degree with at least 4 years experience in a related field.
• Bachelors degree in Chemistry, biology or related science degree with at least 2 years experience in related field.

Experience:

• Demonstrated proficiency working in a quality lab setting or manufacturing/production setting.
• Experience with computer systems and data entry.
• Experience in performing peer review of data.
• Excellent oral, written and interpersonal communication skills within a diverse team setting are required.
• Basic math skills and computer skills such as data entry, along with a high level of attention to detail are required.
• The successful candidate will possess a demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task), and be able to meet objectives in a flexible, team-oriented environment.

Nice-to-Have

• Preferred candidate will have previous laboratory experience, including a basic understanding of microbiology, environmental monitoring, aseptic technique, and/or previous experience in an aseptic manufacturing environment.
• Excellent oral, written and interpersonal communication skills within a diverse team setting are required.
• Basic math skills and computer skills such as data entry, along with a high level of attention to detail are required.
• The successful candidate will possess a demonstrated ability to organize time independently, be able to perform several tasks concurrently (ability to multi-task), and be able to meet objectives in a flexible, team-oriented environment.
• The successful candidate must also have demonstrated the ability to quickly learn new skills/techniques.
• High productivity and the ability to multi-task coupled with a low error rate and attention to detail.
• Must demonstrate flexibility/agility and engagement in a changing environment.
• The candidate is expected to gown in an aseptic environment and display good gowning and aseptic technique to avoid contamination of facilities.

PHYSICAL/MENTAL REQUIREMENTS

• Must be capable of maintaining aseptic gowning qualification in a production environment.
• Must be capable of manual manipulations with fine dexterity.
• Must be capable of walking and/or standing for extended periods, bending, reaching and lifting (less than 35 lbs.) during routine job activities.
• Extended time working at a computer terminal is also required.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

• Must be capable of maintaining aseptic gowning qualification in a production environment.
• Primarily 1st Shift: 6:00AM - 2:30PM Monday - Friday.
  Regularly scheduled Weekend, Holiday, and Overtime hours will be required in order to meet business and/or customer needs.
• Weekend, Holiday, and Overtime hours will be required in order to meet business and/or customer needs.
• Work Location Assignment: On Premise colleagues work in a Pfizer site because it's needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.

Other Job Details:

• Last Date to Apply for Job: December 28, 2023

The salary for this position ranges from $21.32 to $35.53 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 - Kalamazoo 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.
Quality Assurance and Control