1+ months

QC Manager

Pfizer
Andover, MA 01810
**ROLE SUMMARY**

**The qualified candidate will provide oversight and management of raw material sampling and testing in a QC analytical department. The oversight will include routine testing, investigation support and method improvements. The manager will oversee investigations, trending, laboratory compliance and contract testing support. The position includes people leading, employee development, performance reviews and establishing training plans. The manager will help drive department goals, objectives and prioritization.**



**ROLE RESPONSIBILITIES**



+ Ensure raw material testing is completed on time to support plan of record

+ Oversee the raw material sampling group

+ Maintain cGMP compliance and laboratory inspection readiness

+ Review and approve documentation associated with cGMP testing, investigations, change controls and technical reports

+ Coach, mentor and develop direct reports

+ Make decisions and set priorities related to raw material testing, deviations, investigations and projects

+ Assist with method troubleshooting and problem solving

+ Collaborate with colleagues and site functional areas to drive department and site goals and objectives

+ Support installation and/or sustainability of Integration manufacturing excellence (IMEx) system in the labs.

+ Develop a continuous improvement culture within the group and guide lab analysts on use of continuous improvement tools

+ Work with other managers to plan and optimize organizational structures, workload, staffing and budget for QC Analytical.

+ Collaborate across functions while representing QC Analytical on the Materials Program Team

+ Responsible for managing introduction of new raw materials and raw material changes



**BASIC QUALIFICATIONS**



+ B.S or M.S in Biology, Chemistry or related scientific discipline with a minimum of 5-10 years of leadership/management experience in a GMP regulated QC analytical laboratory

+ Strong understanding of analytical testing of compendial (USP, EP, JP) and non-compendial raw materials following laboratory SOPs

+ Demonstrated leadership skills in coaching, development, decision making, planning and prioritization. Focused on team success to meet defined metrics and timelines.

+ Proficiency with computer systems (Microsoft Office applications, LIMS, etc.)

+ Excellent communication skills (oral and written)

+ Knowledge in HPLC, LC/MS, GC, GC/MS, NIR, spectroscopy, IR, XRF, titration, and KF analysis



**PREFERRED QUALIFICATIONS**



+ Understanding of continuous improvement tools and skills (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).

Ability to perform mathematical calculations and to perform complex data analysis.



**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.



+ **Last Date to Apply for Job: 05.08.2020**

+ 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 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

Categories

Posted: 2020-04-20 Expires: 2020-06-19

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QC Manager

Pfizer
Andover, MA 01810

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