• Job Description

  Req#: 4895489

  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 recognized as a subject matter expert with specialized knowledge and skills in procedures, techniques, tools, materials and equipment. You will be entrusted with adapting standard methods and procedures by applying your knowledge, prior work experience and requirements. Your business awareness of cross-organizational impact on project delivery will elevate the quality of project deliverables. You will arrive at decisions on which methods and procedures are the best fit for different work situations.

  You will train others and reinforce behaviors that will help us achieve our goal of providing the best healthcare to our patients.

  ROLE SUMMARY

  The QO Technical Associate lead in Aseptic Plant support is responsible for providing detailed subject matter expertise, training, and schedule/coordination of work team colleagues. Liaison between work team and outside organizations to coordinate calibrations, preventative maintenance, work orders, project work ETC. Responsible for supporting the work team daily operation to ensure that applicable safety guidelines/policies are followed, and that all tasks are conducted in accordance with appropriate procedures and standards, such as FDA's current Good Manufacturing Practices (cGMPs). Update procedures and route through the change control process. Provide support with Technician scheduling and scheduling changes for assigned shift. Provide back up when primary scheduler is not available.

  Using standardized procedures, the candidate will also conduct a variety of microbiological environmental sampling in aseptic processing areas. The sampling performed supports high through-put pharmaceutical manufacturing.

  Provide Total particulate start up testing for the facility on assigned shift.

  In addition to performance of routine environmental sampling, the candidate will assist in the overall operation of the microbiology laboratory including:

  • Incubation of samples

  • Read out of sample results and entry of results into an electronic database

  • coordinate/lead training activities on assigned shift Maintenance of records, equipment, basic lab supplies, and reagents in accordance with current good manufacturing requirements.

  • Second checks documentation, ensures corrections are completed in a timely manner for self and others .

  ROLE RESPONSIBILITIES

  • Assists in the development of Aseptic Plant Support Technicians. Maintain/update training components, provide training, and help track training and status through PLS for colleagues. Establishes efficient processes, while monitoring for specific results and improvement of identified process opportunities. Assists in identifying problems and solutions using M1. Serves as technical subject matter expert for the work team and provides support for deviations as assigned by management. Works with Management and Microbiologists by participating in facility qualification activities. Routes GCR documents for approval in electronic database.

  • As directed by supervision, the Lead may be responsible for day to day Aseptic Plant Support Lab operations, daily assignments, serving as person in charge in the absence of a supervisor, attending scheduling meetings, assisting with incident (event reports or QARs, and reviewing and requesting SOP and document revisions.

  • Additional responsibilities include performing environmental sampling in aseptic processing area.

  - This will include setting up sampling materials and data summaries in a computerized database, incubating samples, and interpreting and documenting results.

  • Recognizes atypical data and informs supervision of relevant problems.

  • Enters, reviews, and approves data in computerized database. May have administrator rights in environmental monitoring database to assist with error correction and troubleshooting.

  • Transports samples and supplies between the laboratory and production environments.

  • Applies technical knowledge of microbiological principles, theories, concepts and Pfizerprocesses and industry practices/standards to their daily work.

  • Is able to work both independently and as part of a team.

  • May perform assays on purchased materials, investigative samples, and in-process samples in a laboratory service operation so that the unit and organizational objectives are met.

  • Performs equipment & laboratory maintenance.

  • Orders and maintains laboratory supplies.

  • Operates within established HR policies and basic colleague relations guidelines.

  • Contributes to the completion of specific team objectives and assigned project milestones.

  Qualifications

  • High school diploma (or equivalent) plus 6 years of experience in a pharmaceutical laboratory or Aseptic manufacturing environment required OR Associates Degree/Bachelor’s Degree in biological sciences with 3 years of experience

  • Good 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.

  • Leader behaviors are an important part of this position especially teamwork, integrity, open discussion and debate, critical thinking and performance. Leader behaviors are an integral part of the job and should always be demonstrated.

  • 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.

  • Previous experience acting as a Trainer, and leadership/mentorship experience is a plus

  
  

  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.
  • This is a Second Shift position (2:00PM – 10:30PM), with potential to move to a 10-hr shift rotation (2:00PM - 12:00AM).
  • Weekend, Holiday, and Overtime hours will be required in order to meet business and/or customer needs.

  OTHER JOB DETAILS

  Last Date to Apply for Job: 10/31/2023

  Work Location Assignment : Onsite

  The salary for this position ranges from $25.59 to $42.65 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

  #LI-PFE

• About the company

  At Pfizer we know that great things happen anywhere people come together with one shared goal. And the greatest rewards are sometimes where you least expect them. The future of medicine is happening at Pfizer.

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