Job Description

ROLE SUMMARY

The qualified candidate will provide technical and documentation support for a cGMP quality control analytical (QCA) laboratory, which includes: oversight of testing, scheduling and participation in cross functional teams to meet customer deliveries, responsibility for product-specific investigations, change controls, technical documents, test methods and APQRs. This is a non-testing support role for multiple products including protein and mAbs with a focus on analytical methods.

ROLE RESPONSIBILITIES

* Support lab testing: Provide guidance for assay troubleshooting, track testing and timelines, review data and documents for compliance and accuracy.
* Meet all timelines and deliverables in the support of the production plan of record and stability program.
* Support change controls, investigations and other technical documents.
* Maintaining cGMP compliance and laboratory inspection readiness.
* Provide audit support for board of health inspections and regulatory responses.
* Support installation and/or sustainability of Integrated Manufacturing Excellence (IMEx) elements within the group.

BASIC QUALIFICATIONS

* Bachelor's Degree in Biology, Chemistry or related scientific discipline with 5+ years of applicable laboratory experience OR MS Degree in Biology, Chemistry or related scientific discipline with 3+ years of applicable laboratory experience required.
* Extensive knowledge and practical application of relevant analytical techniques (analytical/bioanalytical testing and troubleshooting).
* Strong technical writing skills, including investigations.
* Experience with cGMPs, regulatory guidance and audits.
* Demonstrated leadership skills in decision making, planning and prioritization with a focus on team success in meeting defined metrics and timelines.
* Proficiency with computer systems (Microsoft Office applications, LIMS, SMART QC, etc.).
* Excellent verbal and written communication skills.

PREFERRED QUALIFICATIONS

* Strong understanding of continuous improvement tools and skills preferred (standard work, visual management, DMAIC).

PHYSICAL/MENTAL REQUIREMENTS

* Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office and on the floor (laboratory, suites, etc.).

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:

* Eligible for Relocation Package
* Last Date to Apply for Job: April 21, 2021

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Relocation support available

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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