Job Responsibilities:

•    Uses qualifications to perform process steps whenever necessary to support continuous operations, in accordance with Batch Record manufacturing instructions and current labor standards in order to safely and efficiently manufacture a quality product.

•    When necessary for continuous operations, assembles, disassembles, and cleans equipment used for manufacturing in accordance with the applicable GMP procedure to ensure proper operation and cleanliness of the equipment.

•    Performs daily review of batch documentation for accuracy and completeness.  At the end of the batch reviews all batch documentation for accuracy and completeness prior to submitting batch for review.

•    Ensures Operators monitor and document the critical process parameters during the manufacturing process.  

•    Responds to and resolves process & equipment problems independently. Notifies Supervisors and works with other departments (Quality Assurance, Engineering, Technical Services, R&D, etc.) to facilitate resolution of issues. 

•    Works with Quality Assurance and Engineering to ensure the manufacturing process meets quality specifications.

•    Acts as Subject Matter Expert on production procedures to support investigations, CAPAs, projects, new product introductions, and procedure generation and/or revision. 

•    Monitors production schedules. Troubleshoots scheduling conflicts and coordinates Production resources and with other departments to meet production goals. 

•    Trains new employees for new positions, processes, and retrains others as necessary. 

•    Aids Section Leader in assigning qualified personnel as required to meet weekly production schedule including overtime scheduling as needed. Ensures personnel are properly trained and qualified before assigning tasks.

•    Complies with and enforces GMP/GDP standards in order to minimize cross contamination, holding personnel directly accountable for compliance.

•    Ensures housekeeping standards are followed and area is maintained during shift. 

•    Follows all departmental and company safety policies in order to prevent injury to self and others.

•    Backfills associates in the processing rooms as needed.

•    Trains and audits production employees to ensure current approved SOP’s are followed.  

•    Supports and promotes all Environmental, Health & Safety initiatives to ensure compliance with corporate and other regulations.  

•    Performs other duties in order to meet department's production schedule or to comply with cGMPs.

•    Works as a member of the team to achieve all outcomes.

•    Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements.

•    Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion.

•    Ensures area housekeeping / 5S initiatives are sustained, and all other relevant duties as assigned.

•    Works as a member of the team to achieve all outcomes.