QC Laboratory Technician - 2nd Shift/Weekend

ROLE SUMMARY

This position supports commercial manufacturing and QC testing labs by managing sample lifecycle including bulk sample receipt, aliquot, labeling, delivery, and storage of QC test samples. Sample types may include release test, backups, retains, reference material, assay controls, and stability.

Support and maintain retain program as required by CFR regulations. Monitoring of environmental chambers is also critical to the storage of the above sample types.

ROLE RESPONSIBILITIES

• Aliquot of QC analytical test samples from bulk samples in a Biological Safety Cabinet (BSC).

• Perform pre and post aliquot quality checks and review of labels, line clearance, sample handling, and storage conditions.

• Documentation of GMP in-process and drug substance samples in support of Quality Control release testing.

• Adhere to SOPs (Standard Operating Procedures), cGMP (current Good Manufacturing Practices), plant safety, quality, and documentation systems requirements.

• Coordinate receipt and delivery of samples from designated sample ports to QC laboratories or QC cGMP areas and maintain the inventory for retain samples, backup samples and reference material.

Inventory and Equipment:

• Maintain sample inventories

• Monitor and maintain QC Cold storage units. 

• Perform space evaluations for receipt of material.

• Perform discard activities as appropriate on backup samples, retains, and reference material.

• Fill sample requests.

• Participate in on-call program - Be part of the rotation for the on-call program to support critical equipment 24/7.

Other:

• Meetings - Represent the functional group at meetings related to projects, investigations, or issue resolution.

• Investigations - May attend meetings for investigations.

• May cross train in other areas such as QC Biological Shipping and Receiving and QC Sample Management.

Qualifications

Must-Have

• High School Diploma or equivalent with 2+ years of experience in a GMP environment OR Biotechnology Certificate or Associates Degree with 0 – 2 years of experience working in a cGMP environment.  

Nice-to-Have

• Knowledge of basic laboratory techniques such as working in a Biological Safety Cabinet (BSC), pipetting, aseptic technique, and basic laboratory safety practices preferred.

• Experience with Labware LIMS is a plus.

• Experience in a biotechnology laboratory or manufacturing environment preferred.

• Knowledge of GMP concepts and documentation practices.

• Knowledge of basic electronic systems. (Microsoft Office, Outlook, Teams etc.)

  
PHYSICAL/MENTAL REQUIREMENTS

• Work within a BSC

• Ability to use handheld, manual and automated pipettes

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Four (4) 2nd shift positions working a 4 days x 10 hours schedule: :

• Two (2) Sunday to Wednesday 2:00pm to 12:30am
• Two (2) Wednesday to Saturday 2:00pm to 12:30am

Additional Job Details:

• Last Date to Apply for Job: 12 AUGUST 2021
• Eligible for Relocation Assistance: NO

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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

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