QC Coordinator, Stability Operations

Employer
Pfizer
Location
Andover, Massachusetts
Posted
Jul 30, 2021
Ref
4819648
Required Education
High School or equivalent
Position Type
Full time

ROLE SUMMARY

The QC Coordinator, Stability Operations is a member of the QC Stability Group. This position performs sample receipt and handling for stability study initiations (enrollment), timepoint pulls, thawing and aliquoting of drug substance samples, reconstitution of drug product samples and chamber monitoring. Activities performed utilizing software and other electronic systems such as Labware LIMS, EAMS, and QUN. Coordinate activities involving laboratory activities and schedules, serve as an SME within area of responsibility during on-site inspections and audits.  In addition, non-lab support needed for investigations, corrective action/preventative action (CAPAs) and change controls. The person will also support creation and revisions of QC documentation such as SOPs.  Prepares and reviews required documentation following good manufacturing practices (GMP). Utilizes related documentation systems.  Will require participation in the on-call program rotation to support and respond to critical chambers alarms and to transfer material when necessary.

ROLE RESPONSIBILITIES

  • Handles receipt of all Stability samples for enrollment into the QC Stability program and initiation of accelerated and special studies.
  • Inspection of samples at receipt.
  • Creates Monthly Thaw/Reconstitution Schedule.
  • Submit Stability timepoints to the testing laboratories and perform drug substance thaws, aliquoting of samples, reconstitution studies, appearance assays when applicable.
  • Utilize LabWare LIMS when applicable, for recording of Stability information related to stability thaw and reconstitution procedures.
  • Reviews laboratory work for accuracy and compliance with procedures.
  • Maintains QC Stability inventory and verifies calibration of laboratory and sample storage equipment.
  • Assistance with data collection to fulfill the business needs during a QUN failure.
  • Managing of laboratory reagents and materials.
  • General cleaning and upkeep of laboratory.
  • Ordering of laboratory supplies.
  • Takes the initiative to drive process improvements to increase efficiency to work processes and ideas while actively sharing knowledge with others within the group. 
  • Must be able to use proactive thinking to anticipate potential challenges in projects and daily work resulting in a plan of action to mitigate risks.
  • Must have the ability to prioritize responsibilities with respect to daily workload
  • Support creation and revisions of QC documentation such as SOPs.
  • Collaborates with other function areas to resolve issues related to stability sample storage.
  • May represent work group within department teams
  • Participate in on-call program rotation to support critical chambers.

BASIC QUALIFICATIONS

  • High school diploma or equivalent with 2 years of experience in GMP environment. 
  • Relevant Quality experience, preferably in the bio/pharmaceutical industry.
  • Must have knowledge of GMPs and lab experience
  • Proficiency with computer systems (Microsoft Office applications, MS Word, EXCEL).
  • Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential).

PREFERRED QUALIFICATIONS

  • Experience with LabWare LIMS, QTS Trackwise, PDOCS or similar document management systems.
  • Experience with stability chamber performance and monitoring systems (QUN).
  • Proficiency with LIMS desirable.

PHYSICAL/MENTAL REQUIREMENTS

  • Lifting trays/bins of samples in various container types (i.e. plastic bottles, stainless steel etc).
  • Frequent walking, bending, sitting and standing requirements to facilitate support of staff on the floor (Laboratory). 
  • Ability to perform mathematical calculations.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday.  Some off- hour support may be required to support priorities.  Participate in on-call rotation to respond to equipment alarms 24/7 and to transfer material when necessary.

Other Job Details:

  • Last day to apply: 05 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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