QO Specialist - Analytical Services
The Analytical Services group is responsible for the Kalamazoo site Stability, Retain and programs. The successful candidate will ensure the Retain program remains in compliance with both internal and external regulatory requirements through maintenance of area SOPs and training documents, understanding of requirements for handling and storage of controlled substances, annual controlled substance inventory and annual inspection tracking and coordination, and equipment monitoring and periodic reviews. The successful candidate will provide guidance and support to technicians in the area, represent the unit on cross functional project teams, and function as a subject matter expert (SME) during audits.
This position requires excellent interpersonal communication (oral and written) skills; attention to detail, demonstrated flexibility in working, interacting and communicating with diverse individuals/groups and ability to develop and maintain effective customer relationships. This includes but is not limited to assisting team members and customers in investigation and resolution of items outside of the routine workload; assisting customers with special requests or needs; special projects that include changes and improvements to the operations, process revisions to SOPs and test plans using local change control systems (such as QTS) and participating in system development and design. Knowledge and use of the corporate LIMS systems and other computerized systems is required. This role will require the candidate will participate in the Annual Inspection testing of retains samples. The successful candidate will be a back-up professional for the stability area.
- Maintain area SOPs and training documentation and provide any necessary support and guidance to Retain technicians and contractors
- May be assigned other tasks as primary or backup. These assignments may include: audit SME, SOP SME, training responsibilities, authoring of specific job aids, and participation on global teams, presentation of analytical services information to leadership and trending of issues.
- Detail oriented inspection of retain samples for annual inspection. Ensuring all annual samples are tested. Ability to respond to color or special visual indicators to support annual inspection activities and successfully complete the Pfizer Inspection On the Job Training (OJT) on an annual basis.
- Facilitate the preservation of all Analytical Services sample by monitoring EMS and viewlinc. Working with other professionals and Pfizer Maintenance.
- Education: BS in Chemistry, Microbiology, Engineering or other science related discipline
- Experience: Minimum 2 years pharmaceutical experience. Quality Assurance experience required.
- Knowledge and use of quality systems (e.g. LIMS, SAP, QTS) is required
- Excellent organizational skills and demonstrated ability to meet changing deadlines and deliver results on time
- Excellent communication skills to support all levels of customers and maintain effective customer relationships
- Demonstrated agility/performance in a changing environment and have a willingness to be active in continuous improvement initiatives
- Demonstrated ability to work both independently and in a team environment
- Demonstrated commitment to values based leadership and achieving objectives in a manner that is supportive of Pfizer Values and Core Competencies
- Ability to comprehend and apply information from guidance documents (e.g. PQS, CFR) to functional processes
- Familiarity with Retain programs is preferred
Ability to lift up to 35 pounds is required.
Ability to respond to color or special visual indicators to support annual inspection activities and successfully complete the Pfizer Inspection On the Job Training (OJT) on an annual basis.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Generally First shift, 8:00-4:30.
Off-hours/on-call support is required on a rotational basis.
Other Job Details:
- Last Date to Apply for Job: August 10th, 2021
- Eligible for Relocation Assistance: No
- Eligible for Employee Referral Bonus: YES