At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.
Description:
The 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, KRONOS and Trackwise as well as ensuring that OEE performance data is collected as specified for each operating area.
Essential Job Functions:
- Review time entries and make necessary adjustments in the Kronos system.
- 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 Trackwise IDM. Report process deviations when they occur.
- Investigate manufacturing deviations; close out deviations, CAPAs and/or pAFCAs as needed.
- Review completed production documentation (for example: batch records, log books, etc.) 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: Facilitator) 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, etc.
- Wear sterile garments and PPE (Personal Protective Equipment) as required by specific activities.
- Complete required training.
Other Duties:
- 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 labeled, floors, etc.
- Attend inter-departmental meetings to discuss matters involving the coordination of multiple departments.
- Read technical publications and manuals, and write associated procedures.
Minimum Requirements:
- High school diploma or GED required
- Experience in documentation in a GMP environment
- 2-3 Years of experience in a pharmaceutical or GMP 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 Requirements:
- Experience in a production environment
- Bachelor’s degree
- Experience working in a LEAN manufacturing environment
- Knowledge of cGMPs and FDA policies/procedures
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
Date Posted
11-Feb-2020Closing Date
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
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