Associate Manufacturing Specialist

Pfizer • Kalamazoo, MI

1d • Onsite

About The Position

The Associate Manufacturing Specialist designs and develops documentation for Drug Products Operations and is accountable for delivering documentation on time to support manufacturing processes. The role focuses on clear, efficient documentation that complies with current Good Manufacturing Practices and Pfizer Human Performance standards. It supports solutions that meet GMP, Pfizer Quality Standards (PQS), Environmental Health & Safety (EHS), and external regulatory agency requirements in partnership with Drug Product units and leaders.

The specialist coordinates training requirements for assigned operations units, including maintaining training roadmaps, administering learning plans in the Pfizer Learning Academy, and supporting training programs. The role creates and revises SOPs, OJTs, curricula, and other documents; coordinates document changes, consensus, and approvals; and partners with Operations on periodic reviews. Additional duties include impact assessments in the QMS change-management system, supporting EHS and continuous-improvement initiatives, facilitating Drug Product Orientation on a rotating basis, and identifying value-added work.

This is an on-premise role at Pfizer’s Kalamazoo Production Facility, with attendance required five days per week. The schedule is a flexible first shift, with core hours of 8:30 a.m. to 2:00 p.m. Monday through Friday. Flexibility, occasional irregular hours, and periodic evening or weekend work may be needed to support around-the-clock operations. Orientation assignments may also require schedule flexibility, with advance notice.

Requirements

• A bachelor's degree and 0 or more years of experience; or an associate's degree and 4 years of experience; or a high school diploma or equivalent and 6 years of relevant experience.
• Demonstrated good oral and written communication skills.
• Proficiency with computers and Microsoft Office applications, including PowerPoint, Word, Excel, Outlook, and Visio.
• Ability to manage workload and gather information in a dynamic environment.
• Self-motivation and willingness to learn new and changing systems.
• Ability to interact effectively with all levels of the organization.
• Ability to be present at Pfizer’s Kalamazoo Production Facility five days per week.
• Ability to work a flexible schedule, including occasional irregular hours and periodic evening or weekend work.
• Permanent work authorization in the United States; U.S. work visa sponsorship is not available.

Nice To Haves

• Pharmaceutical operations experience.
• Proficiency with Quality Management Systems, such as Vault, Quality Tracking System, or QTS Trackwise.
• Experience with document change-control processes.
• Experience with SOPs, BRs, and EBR.
• Experience with EBR record processing.

Responsibilities

• Design and develop documentation for Drug Products Operations, ensuring timely delivery and clear, efficient formats.
• Support compliance with GMP, Pfizer Quality Standards, EHS requirements, and external regulatory agency requirements in partnership with Drug Product units and leaders.
• Perform administrative tasks in the Pfizer Learning Academy to support learning plans for assigned operations units.
• Maintain training roadmaps for assigned operations units.
• Serve as a responsible person and perform impact assessments for document changes in the QMS change-management system.
• Create and revise SOPs, OJTs, curricula, and other documents using Microsoft Word or other document-authoring applications.
• Facilitate requests for change, prepare draft documents, confirm consensus, and ensure required approvals are completed on time.
• Partner with Operations to complete periodic reviews as required by SOP.
• Facilitate the Qualified Job Task Trainer (QJTT) program.
• Participate in and support EHS initiatives, including the Good Catch program and Incident and Injury Free (IIF) cultural improvements.
• Identify opportunities for continuous improvement in Drug Product compliance and participate in resolution activities, including brainstorming, piloting, and implementation.
• Facilitate Drug Product Orientation on a rotating basis as assigned by management.
• Independently seek value-added work.

Benefits

• 401(k) plan with Pfizer matching contributions and an additional Pfizer Retirement Savings Contribution.
• Paid vacation, holidays, and personal days.
• Paid caregiver/parental and medical leave.
• Medical, prescription drug, dental, and vision coverage.
• Eligibility for Pfizer’s Global Performance Plan, with a bonus target of 7.5% of base salary.
• Relocation assistance may be available based on business needs and/or eligibility.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level