Associate Manufacturing Specialist

ROLE SUMMARY

The Associate Manufacturing specialist role is accountable for the design and development of documents for Drug Products Operations. You will be entrusted with responsibility for on-time delivery of documentation enabling the manufacturing process. You will ensure clarity and efficiency in documentation format, with a focus on current Good Manufacturing Practices compliance and Pfizer Human Performance standards. The focus on the job will contribute to achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues. It is your hard work and focus that will help in making Pfizer ready to achieve new milestones and help patients across the globe. The role supports solutions that comply with Good Manufacturing Practices (GMP’s), Pfizer Quality Standards (PQS), Environmental Health & Safety (EHS) and external regulatory agency requirements with the partnership of the DP Units and leaders.

The colleague is expected to coordinate training requirements for their assigned operations units including the following responsibilities:

o Perform administrative tasks in the Pfizer Learning Academy (PLA) to support the learning plan for their assigned operations unit(s)

o Maintain training roadmaps from assigned operations unit

o Function as a responsible person and performs Impact Assessment for document changes in the Quality Management System (QMS) change management (CM) system

o Create/Revise SOPs, OJTs, curriculum, and other Documents that may be developed in Microsoft Word or other document-authoring applications.

o Facilitate request for change, create draft documents, confirm consensus and assure required approvals are completed on-time.

o Partner with Operations to complete periodic reviews, as required by SOP

o Facilitate Qualified Job Task Trainer (QJTT) program

o Participate and support Environment Health & Safety (EHS) initiatives such as Good Catch program & Incident and Injury Free (IIF) cultural improvements

o Identify opportunities for continuous improvement within DP compliance and participate in resolution activities such as brainstorming, piloting, and implementation

o Responsible for facilitating Drug Product Orientation (DPO) on a rotating basis as assigned by management. Orientation assignments may require flexing working schedule to accommodate, but advanced notice will be given.

o Independently seeks value Added Work

BASIC QUALIFICATIONS

o Applicant must have a bachelor's degree with 0+ years of experience; OR an associate's degree with 4 years of experience; OR a high school diploma (or equivalent) and 6 years of relevant experience

o Demonstrated good oral and written communication skills

o Proficiency in use of computers and Microsoft Office Applications (PowerPoint, Word, Excel, Outlook, Visio)

o Ability to manage workload and gather information in a dynamic environment

o Self-motivated and willing to learn new and changing systems

o Ability to interact effectively with all levels of the organization

PREFERRED QUALIFICATIONS

o Pharmaceutical experience in operations

o Proficiency in use of Quality Management Systems (Vault, Quality Tracking System, QTS Trackwise)

o Experience in document change control processes

o Experience with SOPs, BRs, and EBR

o Experience with EBR record Processing

PHYSICAL/MENTAL REQUIREMENTS

PHYSICAL/MENTAL REQUIREMENTS

Physical Demands:

o Long periods of sitting in an office environment

o Long periods of standing and traversing hard surfaces

o PPE and gowning requirements in varied production environments

o Must be present at Pfizer’s Kalamazoo Production Facility 5 days/week to support operations via face-to-face meetings

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

This position works a flexible first shift schedule. Core hours are 8:30a-2p Monday-Friday, but may require flexibility based on production requirements. This position requires the ability to work in a remote office environment and will require periodic weekend or evening work supporting a 24-hour/7 day operation. Must be able to work irregular hours on occasion

Relocation assistance may be available based on business needs and/or eligibility.

Candidates must be authorized to be employed in the U.S. by any employer.

U.S. work visa sponsorship (such as TN, O-1, H-1B, etc.) is not available for this role now or in the future.

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.  This position requires permanent work authorization in the United States.

Pfizer endeavors to make www.pfizer.com/careers accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.com. This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Requests for any other reason will not be returned.

To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers.