Job Description

ROLE SUMMARY

The Quality Control Analytical group is seeking a highly motivated and experienced candidate to support GMP analytical non-testing activities for the Raw Materials group at the Andover site. This candidate is responsible for writing, procedures, test methods, technical documents investigation reports, raw material specifications and change controls.

This position requires working collaboratively with the QC raw materials team (QC Analytical, QC Micro, Quality Assurance, Warehouse, Supply Chain and Site Technical Services).

This candidate will actively participate in scheduling, visual management, metrics, and continuous improvement activities. The successful candidate will be team oriented, have a passion for excellence, act with integrity, demonstrate equity and inclusivity, seek continuous improvement opportunities, actively participate in site recognition programs and take pride in his or her contribution to the team.

ROLE RESPONSIBILITIES

In order of importance, indicate the primary responsibilities critical to the performance of the role. It is recommended not to list actual tasks but focus on 5-8 essential responsibilities that highlight accountability and level of judgment required.

ROLE RESPONSIBILITIES

* Writing and reviewing technical documents such as raw material specifications, standard operating procedures and test methods.
* Represent Quality Control Analytical in cross functional and site product meetings.
* Support internal and external audits.
* Plan and prioritize assignments
* Perform analytical documentation activities of raw material samples.
* Record and maintain all related data and records in compliance with cGMP and quality procedures.
* Meet all timelines and deliverables in the support of the plan of record.
* Support atypical or out-of-specifications test results, participate in investigations for resolution and correction.
* Review data and documents for compliance and accuracy.
* Participate in continuous improvement culture within the raw materials group. Utilize continuous improvement tools.
* Participate and use 5S, standard work, and visual management tools and processes.
* Perform work consistent with Pfizer Values of Courage, Excellence, Equity, and Joy

BASIC QUALIFICATIONS

* Minimum B.S./B.A. in Biology, Chemistry or related scientific discipline with a minimum of 3 years QC GMP pharmaceutical or biotech industry. M.S. with a minimum of 2 years of related experience.
* Experience working in QC testing laboratory in GMP environment in pharmaceutical industry
* Scientific understanding and experience with laboratory instrumentation and techniques such as HPLC, pH, titrations, UV and wet chemistry techniques.
* Knowledge and experience in cGMP test methods utilizing and applying compendial monographs and procedures such as USP/NF, EP, JP
* Proficiency with computer systems (Microsoft Office applications, LIMS, etc.).
* Strong oral and written communication skills
* Candidate must be self-motivated and be able to adapt to rapidly changing project priorities.

PREFERRED QUALIFICATIONS

* Experience with QC Raw Material testing and documentation.
* Knowledge and experience in cGMP USP/EP/JP, regulatory guidance and audits.
* Experience with electronic document management systems and laboratory information management systems such as LIMS, SAP, PDOCs, and Trackwise strongly preferred.
* Experience authoring and reviewing QC documentation such as SOPs and test methods.
* Experience authoring quality documents such as change controls, CAPAs, deviations
* Experience with DMAIC, lean, and continuous improvement tools desired

PHYSICAL/MENTAL REQUIREMENTS

Normal lifting, sitting, standing, and walking requirements to facilitate testing in a laboratory environment.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

Position is first shift Monday through Friday. Some off hour (night/weekend/holiday) support may be required to support staff and operations.

Other Job Details:

* Last Date to Apply for Job: 05 MARCH 2021
* Eligible for Employee Referral Bonus

LI-PFE

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 providers 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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