The position is responsible for overseeing packaging and inspecting of pharmaceutical products in accordance with packaging instructions, Standard Operating Procedures (SOP), and current Good Manufacturing Practices (cGMP) while adhering to health and safety requirements.

• Provide leadership and direction to production associates in the inspection and labeling of product by delegating duties and ensuring packaging operations are completed in a timely manner and according to SOP’s.
• Perform packaging line start-ups, shutdowns, and clearances. Ensure complete and accurate set-up of line for production lot. Document all required clearance steps in the Packaging Work Order (PWO), following all applicable SOP’s. Ensure all required documentation is complete and correct.
• Always utilize safe work practices (i.e. Proper Bending/Lifting techniques, Chemical Awareness, Slip/Trips/Falls awareness, etc.)
• Responsible for ensuring adherence to production schedule and identify discrepancies to include sanitization, material handling, rework, units produced, downtime, etc.
• Conducts daily audits of cGMP paperwork filled out by themselves and co-workers following the completion of sanitization activities. Always ensure proper Good Documentation Practices (GDP) when completing required documentation.
• Perform on the job training as required.
• Inspect product for defects and respond accordingly.
• Coordinate and manage all off-line reworks.
• Daily resource planning including scheduling of production associates to lines.
• Attend daily pass down meetings at the beginning and end of every shift.
• Provide break coverage for production associates as needed.
• Monitor MasterControl accounts to ensure production associates are compliant in their training.
• Maintain work area in a neat and orderly manner and clean equipment as appropriate. Ensure that there is no debris or extraneous items at workstation or in the packaging line area.
• Inform production leadership of product or equipment problems.
• Maintain effectiveness of the Quality System components relevant to this position.
• Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
• Other duties as assigned.

Education or Equivalent:

Experience:

• Minimum one year experience working in manufacturing, preferably pharmaceuticals 
• Experience in a packaging operation beneficial.
• Experience in performing dimensional evaluations desired.
• Functional testing experience desired.
• Demonstrated leadership ability. 

Knowledge/Skills Requirements:

• Should be familiar with cGMP and safe work practices.
• Must be proactive and willing to take initiative and responsibility.
• High level of attention to detail.
• Demonstrated ability to read, write, and speak clear English.
• Excellent documentation skills utilizing Good Documentation Practices (GDP) with the ability to review for accuracy and logic.
• Strong problem solving and analytical skills that incorporates basic mathematical and reasoning abilities.
• Works well in a team environment. Fosters teamwork to get results. 
• Possess and demonstrate excellent verbal, written and interpersonal communications skills allowing for direct interaction with outside suppliers, Managers and Site Leadership. 
• Must be able to interact effectively with a variety of individuals and personalities within and between departments.
• Must be computer literate with MS Office (i.e. Word/Excel/PowerPoint) and shop floor ERP & PSR systems (JDE preferred).
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Perform independent work related to projects and/or routine activities.
• Meet deadlines and work under pressure with limited supervision.
• Must be able to communicate, both written and verbal form, in an effective manner.

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.