Process Coordinator, Filling - (West Chester, OH) - West Chester, OH | Biospace
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Process Coordinator, Filling - (West Chester, OH)

AstraZeneca Pharmaceuticals LP

West Chester, OH
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: West Chester,
United States
Job reference: R-010429

Posted date: Jul. 06, 2017

At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life. As a Process Coordinator, Filling in West Chester, OH, you’ll play a pivotal role in channelling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.

As the Process Coordinator, Filling, you will be responsible for performing 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.
  • 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.


Essential Requirements:

  • Experience in documentation in a cGMP environment
  • High school graduate, vocational school graduate or equivalent
  • 3 Years of 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

Desired Background:

  • Experience in a production environment
  • Bachelor’s degree or equivalent
  • 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.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law.