QO Technical Associate II

Employer
Pfizer
Location
Kalamazoo, Michigan
Posted
May 16, 2022
Ref
4853076
Required Education
High School or equivalent
Position Type
Full time
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.

  • Complete training activities and maintains records, equipment, and basic lab supplies, 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.

ROLE SUMMARY

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

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

  • Completion of training activities

  • Maintenance of records, equipment, basic lab supplies, and reagents in accordance with current good manufacturing requirements.

  • Second checks records and assists in training others.

Primarily Third Shift: 10:00PM- 0630AM Monday – Friday

Regularly scheduled Weekend, Holiday, and Overtime hours will be required in order to meet business and/or customer needs.

ROLE RESPONSIBILITIES

Primary responsibility is to perform environmental sampling in aseptic processing area.

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

  • Recognizes atypical data and informs supervision of relevant problems.

  • Enters, reviews, and approves data in computerized database.

  • Will second-check the work of others.

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

  • Applies technical knowledge of microbiological principles, theories, concepts and Pfizer processes 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

Must-Have
  • High school diploma (or equivalent) plus 2 years of relevant experience; in a laboratory, QA role, or manufacturing environment; Or Bachelor’s Degree in biological sciences plus 6-12 months of experience required.

  • 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.

  • Preferred candidate will have previous laboratory experience, including a basic understanding of microbiology and aseptic technique, and/or previous experience in an aseptic manufacturing environment.

Nice-to-Have
  • Bachelor's Degree

  • Quality Control experience in a pharmaceutical industry

  • Experience in a GMP environment


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 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 Third Shift position (10:00PM – 06:30AM)

  • Weekend, Holiday, and Overtime hours will be required in order to meet business and/or customer needs.

Last Date to Apply for Job: May 27th, 2022
Eligible for Relocation Package: NO
Eligible for Employee Referral Bonus: YES
#LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

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