A world leader in the field of in vitro diagnostics for over 55 years, bioMérieux provides diagnostic solutions that detect disease and contamination to improve patient health and ensure consumer safety. In North America we have more than 5,000 team members across 12 sites or subsidiaries, including Salt Lake City based BioFire Diagnostics. We believe in the power of diagnostics and bioMérieux sponsors public health initiatives and partnerships to address antimicrobial resistance, sepsis awareness, food safety, and consumer health across the globe. Come be a part of our mission to help save lives. Position Summary:
The Production Coordinator position is responsible for the batch record review process for manufacturing/packaging, support manufacturing/packaging for related SAP inputs. This position supports the department's continuous process improvement efforts through the use/implementation of documentation innovation and quality related processes; thereby aligning and consolidating procedural documents as needed. Main Accountabilities: Maintain the expense item inventory for assigned area. Lead and perform batch record review and process documents in a timely manner to maximize product availability for customer demand. Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making. Express ideas clearly (verbal and written) with the ability to work from verbal and/or written instructions, manuals, work orders and specifications. Generate, maintain, issue, and track all electronic and hard-copy controlled documents in accordance with company policies and regulatory agency (e.g., FDA and ISO) requirements. Provide assistance with the review and revision of Manufacturing Directions forms, and departmental SOPs necessary for the manufacture and packaging of product. Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns. Complete process orders in SAP. Perform key user/coach duties to support manufacturing and Supply Chain. Comply with all safety policies and procedures at all times. Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties. Perform computer applications and SAP Material Master data updates as needed to maintain products data accuracy . Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements. Demonstrate and work towards developing the following attributes:
Perform other duties as assigned by Management. Studies and Experience: A High School Diploma or GED equivalent and a minimum of 3 years in a GMP regulated production/operations environment required (pharmaceutical/biotech preferred). Associates Degree in an applicable or Technical field or Vocational / Technical School preferred. Skills and Qualifications: Capacity to understand all manufacturing or packaging specifications, requirements, and procedures adequately to confirm conformance and to provide input regarding the quality/compliance of each. The ability to function in a structured/organized manner. The ability to follow through on assigned tasks in a timely manner. The ability to meet quality/production initiatives. Manage multiple assignments and prioritize them accordingly Strong interpersonal skills. The ability to work as part of a team with minimal supervision. Knowledge of FDA and/or GMP regulations preferred. Prior ERP experience preferred. Prior Microsoft Office tools experience preferred. Proficient in the use of computers. Must carry a cell phone and be immediately accessible by telephone in order to respond to work inquiries or emergencies. Attention to detail and the ability to accurately interpret technical documentation are critical. Physical Requirements:
- Being open to change and new information; adapt behavior or work methods in response to new information, changing conditions, or unexpected obstacles.
- Show understanding, courtesy, tact, concern, and respect to others; develop and maintain positive working relationships with others; may include effectively dealing with individuals who have different viewpoints; relate well to individuals from varied backgrounds.
- Performs all job functions and responsibilities in a safe and responsible manner.
- Ability to sit and/or stand for extended periods of time, as work involves performing computer applications. Ability to work overtime as required to support a 24/7 production operation.
- Ability to maintain reliable and punctual attendance
- May be exposed to chemicals, antibiotics and/or hazardous materials.
- May be exposed to strong odors incurred during media production or other operations.
- Visiting lab and operations areas require wearing various types of PPE which include but is not limited to - a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas of Manufacturing.
Joining bioMérieux, is choosing to join an innovative company with a long term vision, committed to the service of public health and carried out with a humanistic corporate culture. Our Group offers numerous possibilities: so come and join the 13,000 bioMérieux team members who already identify with these values!
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity/GINA.
Job ID: 15690 Nearest Major Market:
Durham Nearest Secondary Market: