layiq
worthy; deserving; fitting; suitable.
A role, opportunity, or path that merits attention, time, and pursuit.
Loading LAYIQ…Job opportunity
Resilience US
USA - OH - West Chester
Source: Resilience US careers · View original posting
From Resilience US's posting. “We” and “our” refer to the employer.
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.
For more information, please visit www.resilience.com
Job Summary
The Specialist II, Manufacturing Process Coordinator, 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.
Job 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.
6am - 6:30pm
2/2/3 Schedule (12-Hour Rotating)
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
Employer posted: