Specialist II, Manufacturing - Process Coordinator; BLU), Dayshift

Position: Specialist II, Manufacturing - Process Coordinator (BLU), Dayshift
A career at Resilience is more than just a job - it's an opportunity to change the future.

Resilience is a technology-focused biomanufacturing company that's changing the way medicine is made. We're building a sustainable network of high-tech, end-to-end manufacturing solutions to better withstand disruptive events, serve scientific discovery, and reach those in need.

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Brief

Job Description:

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.

Job 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 via Veeva. 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 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.

Minimum 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.

Preferred Background

* 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…