Why Patients Need You
This position supports commercial manufacturing and the QC testing labs by managing the delivery and storage of 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.
How You Will Achieve It
Primary responsibilities may include the following:
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.
Adhere to Good Manufacturing Practices (cGMP) and proper documentation practices with generating, reviewing, and reconciling department records.
Utilize sampling plans effectively and report any problems or adverse quality events to management and Quality Assurance.
Maintain sample inventories and monitor and maintain QC Cold storage units. Perform space evaluations for receipt of material.
Assist in sampling for laboratory control testing, stability testing, and other special purposes.
Data entry and distribution of inventory reports.
Participate in on-call program - Be part of the rotation for the on-call program to support critical equipment 24/7.
Meetings - Represent the functional group at meetings related to projects, investigations or issues.
Investigations - May attend meetings for investigations.
Undertake other duties related to Quality Control or special projects as assigned, manage personal time and growth, and participate in process improvement teams.
Other:
May cross train in other areas such as QC Biological Shipping and Receiving, QC Sampling Operations, Solutions Chemistry, and QC Stability Operations.
Additional related activities:
Data entry and distribution of inventory reports
File and archive data.
Perform discard activities as appropriate on backup samples, retains, and reference material.
Fill sample requests.
Investigations - May attend meetings for investigations.
Qualifications
Must-Have
High School Diploma or equivalent required with 4 years of experience
2 years of experience working in a cGMP environment.
Competency with computers required.
Must be detail oriented and be able to work under pressure to meet deadlines.
Ability to work effectively in a collaborative team environment
Nice to have
Biotechnology Certificate
Labware LIMS Experience
Experience working in a GMP facility
PHYSICAL/MENTAL REQUIREMENTS
Ability to lift up to 50lbs (assisted)
50-75% of time standing and/or walking
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
1st shift, Monday through Friday. May require weekend/holiday coverage as needed
Other Job Details:
Work Location Assignment: On Premise
Last day to apply: April 2nd
Relocation assistance may be available based on business needs and/or eligibility.
Candidates must be authorized to be employed in the U.S. by any employer.
U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.
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.
Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.