Specialist II, Manufacturing (dayshift)

Resilience•West Chester, OH

2d•Onsite

About The Position

This position: 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 EDMS/QMS system (Veeva) as well as ensuring that OEE performance data is collected as specified for each operating area. This is a dayshift position Monday-Friday, 8 hour days.

Requirements

Experience in documentation in a cGMP environment
Experience in a pharmaceutical or cGMP 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
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.
Daily and weekly coordination of activities to ensure production schedule is met.
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.
Communicate policies and procedures to employees.
Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
Lead training on all document modifications prior to effective date.
Initiate appropriate action when process deviations occur.
Report process deviations when they occur.
Investigate manufacturing deviations; close out deviations, CAPAs and/or AFCAs as needed.
Review completed production documentation (for example: batch records, log books, 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.
Alert others (for example: Supervisor/Manager) when problems occur outside of SOPs (Standard Operating Procedures).
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.
Gather, organize, and communicate operational information to others.
Lead process improvement activities and teams to meet strategic goals.
Create training modules and/or resources to ensure that SOPs (Standard Operating Procedures) are covered.
Monitor key performance indicators to meet strategic goals.
Monitor training of employees to ensure compliance.
Perform quality audits and walk-throughs to check calibration tags, eye wash station, anything labelled, floors, and so on.
Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
Read technical publications and manuals and write associated procedures.