Contract Manufacturing is responsible for the introduction of new products from companies outside of Legacy Hospira, a Pfizer Company (Pfizer). The department is responsible for coordination of clinical, stability, and commercial production. The department works with all plant departments to coordinate the required activities to manufacture products for the third party customer. Contract Manufacturing is responsible for 1/3 of the units manufactured at this plant.
The Specialist coordinates and performs receipt of bulk drug products, completes required documentation and performs steps to acquire, package and ship customer samples, and coordinates shipment of finished goods.
The Specialist assists in the development of documentation and processes for the introduction of new customers and products.
The individual Specialist has a high level of responsibility in that the majority of tasks are completed without additional support and often without secondary verification.
Specialists assists Contract Manufacturing Analysts on key tasks for new and current third party products. Includes: batch record development and revision, material receipt and release, shipping requests, customer interaction and representing Contract Manufacturing at plant planning/scheduling meetings.
Specialists are responsible for the following major tasks:
1. Coordinates and performs receipt, storage and release of critical raw materials and bulk solutions with a value of up to $1.5 million. This includes delivery of critical ID samples, coordinating material release and final QA approval which requires attention to detail and understanding of material requirements for all phases of manufacturing of the product.
2. Responsible for interacting with customers to supply critical information, project updates, and batch record information. Requires a working knowledge of all plant systems.
3. Responsible for ensuring completion of review and copying of batch records for delivery to customer which is required for product release.
4. Coordinates all activities to ensure any missing information is corrected and delivered to Batch Release for timely release of all batches scheduled for shipment to meet LBE.
5. Responsible for labeling, interim final packaging, and documentation for products with values of up to $10 million – often without secondary verification.
6. Procures and delivers API, components, and sampling documentation to the production area to meet product delivery deadlines.
7. Develops, revises, routes for approval, and tracks the following critical documents: SOP’s, BOM’s, Information Sheets, Quality Issuance Guidelines, Batch Records, Experimental Checklists, sampling records, material transfers, component and shipping requests, and master product code information tables which control key batch record information.
8. Responsible for sourcing, ordering, ensuring installation and procuring validation of new and existing freezers, which can be vital to product storage.
9. Responsible for assisting the "Person in the Plant" when they are in the plant. "PIP’s" are representatives of third party customers that have offices in the plant. Requests may include gathering information, contacting Pfizer personnel, and making copies.
10. Responsible for escorting PIP’s and other third party customers throughout the plant for observation of manufacturing and packaging processes for their product no matter time of day/night, or day of the week.
11. Prepares samples, finished product, materials, and equipment for shipment.
12. Communicates with all plant departments to ensure final product packaging, material and labor planning needs for Contract Manufacturing products, and critical analytical product requirements are met.
13. Responsible for coordinating and representing Contract Manufacturing at meetings and task forces for critical multi-discipline projects that affect the department.
14. Any other duties as requested by Contract Manufacturing Analysts and Manager.
Non-essential duties of incumbent are as follows:
· Safety audits and monthly logbook review.
· Quality, cost, and productivity improvements for the department.
· Attend the weekly staff meeting.
· Participate on an internal assessment team.
· Complete monthly metrics.
· Participate in Six Sigma.
EEO & Employment Eligibility
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Eligible for Employee Referral Bonus
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