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Kalamazoo, MI
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Job Details

**Role Summary**

The Active Pharmaceutical Ingredient (API) In-Plant Lab (IPL) Specialist possesses strong knowledge of API In-Plant Laboratory equipment/technologies, API operations, Standard Operating Procedures (SOPs), GMP's, standard work with focus on continuous improvement as well as strong organizational, communication and people skills.

The API In-Plant Specialist uses their knowledge and expertise to prepare and maintain assigned unit in-Plant Laboratories in a ready state aligning with assigned API unit production schedules.

API IPL Specialist manage assigned projects and installations to meet deadlines, have the ability to adjust and respond to frequently changing priorities, interacts and communicates effectively with colleagues and contract resources across multiple business units to develop and update API In-Plant ASR, methods and training documents.

API In-Plant Lab Specialist are also tasked with design, development, scheduling and delivery of training solutions for API In-Plant Laboratory tasks and related equipment operations.

The API In-Plant Lab Specialist uses acquired API operations/IPL experience, computer applications as well as methodologies to design and deliver effective training solutions that comply with, Good Manufacturing Practices (GMP's), Lab Standards, Pfizer Quality Standards (PQS1228), Environmental, Safety and external regulatory agency requirements.

**Role Description**

API In-Plant Lab Specialist will be responsible for, but not limited to the following tasks:

+ Maintain and prepare API IPL Laboratory Equipment/supplies and consumables for production use, aligning with API unit production schedules.

+ Develop and update API Production ASR documents and assay transfers from Rapid Turn Lab to API In-Plant Lab as requested and when within registration.

+ API In-Plant Lab Equipment procurement, Installation Qualification/Operation Qualification (IQ/OQ), calibrations and IPL Periodic Review.

+ Interact with business area leadership, unit leadership, subject matter experts and operators to develop, author and maintain API In-Plant Lab training documents (e.g. SOPs, User Guides, Job Aids, On Job Training Checklists and IPL Job Task Curricula). Post, maintain, track and reconcile In-Plant Lab documents within the site working copy system.

+ Schedule and deliver API level In-Plant Lab On-the Job Training; HPLC, GC, TLC, Brix, KF, etc.

+ Role requires data entry into Pfizer's Learning Solution (PLS) in a timely manner and generated reports from PLS as needed to monitor and communicate training status and completion of assigned IPL curricula as well as items and requirements identified within assigned curricula to leadership.

+ Interacts with Site, API, unit leadership, as well as shop floor operators, subject matter experts, API training team, Quality, EHS colleagues and external regulatory agencies (e.g. FDA, EPA etc...).

+ Work with API training team leader, unit leadership, subject matter experts, operators and API training team to continuously review and improve unit training and curricula.


+ Relevant degree/certification with laboratory/technologies experience, Or High school diploma / general education degree (GED), Completion of the API Chemical Operator Training Program and 4 years API Production/IPL Experience

+ Works independently and in team setting

+ Strong mechanical aptitude

+ Lab technologies experience = (i.e. GC, HPLC, TLC etc.)

+ Empower software experience helpful

+ Excellent computer user skills are required (Microsoft office)

+ Excellent communications Skills

+ Flexible, Strong work ethic and the ambition for continuous improvement

**Physical/Mental Requirements**

+ API production environment with travel between API production buildings in varying weather condition

+ Requires safe handling of solvents , reagents and hazardous materials within handling and emergency procedures

+ Requires use of PPE for Production Area and API In-Plant Lab entry

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

+ Primary Working Hours: Monday - Friday 7:00AM - 3:30PM

+ Weekend, Holiday, Off-shift Call-in and Report-in expected to provide API production IPL support and continuity.

+ No travel is expected

**Organizational Relationship**

The API In-Plant Lab Specialist is required to interact closely with site API/unit leadership, production engineers, KPT, RTL quality, EHS colleagues as well as unit production colleagues, subject matter experts and contract service providers. The API In-Plant Laboratory Specialist may also be required to interact with external regulatory agencies to support and address audit observations.

**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.

**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.

+ **Last Date to Apply for Job: 2/8/2018**

+ Eligible for Relocation Package

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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