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Kalamazoo, MI
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Job Details

**Role Summary**

The QO Validation Chemist works in a fast paced customer-oriented, laboratory environment to support a variety of customers from across the plant. The QO validation labs consist of three main focus areas including Method Validation, Cleaning Validation and Early Stage testing. The successful candidate will have responsibility in one area but may shift depending on need.

**Role Responsibilities**

Responsibilities could include: Validation of new/existing methods for intermediates, raw materials, in process controls, API, Drug Products and surface monitoring of residues; Troubleshooting and/or improving established analytical test methods. Support product transfers/new product development, regulatory queries, cost improvement projects or DP plant support for Cleaning Validation.

The QO Validation Chemist depending on area of focus could perform the following duties:

+ Write method validation protocols and reports

+ Write cleaning validation protocol and reports

+ Execute analytical method validations

+ Execute cleaning validation protocols

+ Provides technical review of others' analytical data

+ Supports regulatory queries/site compliance initiatives in an ever-changing regulatory environment.

+ Performs method transfers to and from other Pfizer sites and to and from 3rd party sites.

+ Provides compendial method review and interpretation.

+ Provides subject matter expertise in the area of analytical chemistry and method validation to customers, including QC Laboratories, other Pfizer sites, customers, CMC and QA.

+ Supports unit and departmental technological, right first time (RFT) and efficiency improvement initiatives.

+ Supports the unit where needed to assure due dates and customer needs are met.

+ Perform surface sampling of production equipment


+ A BA/BS degree or higher in organic, analytical, physical or biochemistry or another relevant scientific discipline with 3-5 years' experience.

+ Analytical method development and/or validation experience preferred if focus for MV or ESTL. Several years' experience in one or more of the following analytical disciplines required: HPLC, GC, Particle Size Analysis, Spectroscopy, ICP-MS, Bioanalytical techniques (for example, electrophoresis, ligand binding approaches)

+ A fundamental understanding of laboratory instrumentation function and analytical method troubleshooting and a dedication to meeting timelines

+ This position requires an excellent working knowledge of Good Manufacturing Practices (GMPs). The successful candidate must possess the ability to work with a sense of urgency and the ability to prioritize tasks.

+ Excellent oral and written communications as well as strong technical and analytical problem solving skills are critical.

+ This position requires a continuous improvement/innovative mentality.

**Physical/Mental Requirements**

Depending on the focus area, the position could involve:

+ Working in a laboratory environment, which may include standing for long periods of time

+ Working in a production environment which will include the proper gowning for the area

+ Lifting items (typically less than 25 lbs)

+ Working with or around chemicals.

+ The position also requires office work, which includes working at a computer workstation.

**Non-Standard Work Schedule, Travel, or Environment Requirements**

+ The position may require colleagues to work off-hours, weekends and/or holidays to meet business or customer needs.

+ Travel is rare but may be necessary to support transfer project

+ If Cleaning Validation focused, proper gowning for the production areas, including aseptic gowning, will be required.

**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.


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.

**Additional Offer Details:**

+ Last Date to Apply for Job: December 4, 2017

+ This job is Pfizer/Exempt (US/PR) Grade: 04

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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