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Formulation PET Process Coordinator - Mt. Vernon - Global Operations

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 Formulation PET Process Coordinator in Mt. Vernon, IN, you'll play a pivotal role in channeling 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.
Global Operations is fundamental to our purpose of delivering life-changing medicines to patients, touching every aspect of our business and providing a platform for everything that we do. We harness the specialist talents of 13,000 people around the world - 20% of our global workforce. With 30 production facilities in 18 countries we're focused on supplying our medicines with care, quality and efficiency, reducing the time from lab to patient. Keen to bridge the gap between science and patients? Turn research into reality? And forge a global career that's full of possibilities, as part of a world-class team? Come and thrive in our vibrant, energizing, connected and supportive culture and make a real difference to patients.
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.
Advanced knowledge and understanding of equipment and manufacturing processes.
Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable.
Communicate policies/procedures to employees and collaborate effectively with Process Facilitator.
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 investigation process when process deviations occur. Gather initial information and involve support groups 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, for cGMP (Good Manufacturing Practices) manufacturing of commercial product.
Coordinate cross-functionally with other departments as required.
Monitors GMP conditions on the production floor and performs proactive process corrections.
Alert others (for example: Facilitator) when problems occur outside of SOPs.
Attend team meetings to discuss progress, initiatives, and/or other matters.
Read, understand, and comply with cGMP and SOPs, 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 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 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, etc.
Attend inter-departmental meetings to discuss matters involving coordination of multiple departments.
Read technical publications and manuals, and write associated procedures
Qualifications:
Education:
High School diploma or equivalent.
Required:
Experience in documentation in a cGMP environment.
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.
Desirable:
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.


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