Specialist II, Manufacturing Process Coordinator (Day shift and Night shift)

Resilience•West Chester, OH

1d•Onsite

About The Position

The Specialist II, Manufacturing, performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include assisting with manufacturing investigations; issuance, revision, and authoring of documents; maintaining team production metrics for shift. The position provides oversight, execution, and approval for transactions in SAP and Veeva as well as ensuring that OEE performance data is collected as specified for each operating area.

Requirements

Experience in documentation in a cGMP or regulated environment
Must have the ability to effectively understand, read, write, communicate and follow instructions in the English language.
Good attention to detail is required.
Individual must be capable of keeping accurate records and performing mathematical calculations.

Nice To Haves

Experience in a production environment
Experience in a pharmaceutical or cGMP regulated environment
High school graduate, vocational school graduate or equivalent, Bachelor’s degree or equivalent
Experience working in a LEAN manufacturing environment
Knowledge of cGMPs and FDA policies/procedures

Responsibilities

Maintain an advanced knowledge of the SAP system and execute SAP transactions as required to complete process orders.
Technical writing to include investigations, line assessments, and corrective actions.
Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable.
Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
Investigate manufacturing deviations; close out deviations, CAPAs and/or change actions as needed.
Review completed production documentation (for example: batch records, logbooks, and so on) for quality, completeness, and cGMP compliance.
Author/Approve/Review/Revise/Audit SOPs, Work Instructions, and MBRs (Master Batch Records) for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
Coordinate cross-functionally with other departments as required.
Attend team meetings to discuss progress, initiatives, and/or other matters.
Read, understand, and comply with cGMP (Good Manufacturing Practices) and SOPs (Standard Operating Procedures), including general safety, lock outs, and so on
Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
Complete required training.
Complete duty-based packets by reading SOPs (Standard Operating Procedures) and excerpts from technical documentation.