Job Purpose: 

Secondary Packaging’s main objective is to place primary packaged products into outer packaging that provides additional protection for distribution and retail. The secondary packaging process ensures the safe, compliant, and efficient transport of the pharmaceutical products.

Essential Duties and Responsibilities:

• Monitor the operation of Secondary Packaging equipment to determine trends (i.e. vials per minute and pallets packaged      per shift.
• Responsible for overseeing changeovers and end of lot procedures.
• Responsible for reconciliation in the MBR.
• Responsible for training new personnel on your shift. 
• Responsible for starting, stopping and repairing minor problems with Secondary Packaging equipment. 
• Initiate and manage any document, equipment, or process change related to non-conformance investigations as      corrective/preventive action.
• Coordinate training sessions on new documents or processes.
• Ensure completion and implementation of CAPAs (corrective/preventive actions).
• Coordinate and update the daily packaging schedule in the absence of the Operations Manager.
• Initiate, create, and manage any document, equipment, or process change as delegated by Operations management.
• Writes or reviews manufacturing procedures and related document.
• Prepare and review internal documentations for management and production staff.
• Participates in internal GMP audits and supports customer and regulatory audit response. 
• Assists with additional work duties or responsibilities as evident or required.
• Performs other duties as assigned or apparent.

Supplemental Functions: 

· Work under the direction of the Director or designee. 

· Assure the efficient performance of all department equipment.

· Assist with housekeeping as needed.

· Adhere to GMPs and hold those around them accountable.

Job Specifications and Qualifications: 

Knowledge & Skills: 

• Knowledge of the Pharmaceutical of Manufacturing Industry preferred.
• Must be able to pass a Drug Test.
• Must speak, write, and read English.
• Specific expertise, skills and knowledge gained through education and experience.
• Ability to take strategic objectives and accept accountability to drive results through effective actions.
• Ability and willingness to change direction and focus to meet shifting organizational and business  demands.
• Ability to effectively manage one self, demonstrates integrity, be productive under pressure, and achieve development goals. 
• Ability to create new products and processes that add value to the business by generating new ideas, applying creative, and analytical approaches.
• Ability to prioritize tasks, manage time efficiently, and meet deadlines.
• Familiar with relevant industry regulations and compliance standards.
• Incumbents required to wear safety glasses, hearing protection and other non-specified protective equipment as necessary.
• Strong critical thinking, analytical, problem-solving, and interpersonal skills.
• Strong organizational skills with the ability to manage multiple projects or assignments simultaneously.

Education/Experience: 

• High school diploma or equivalency is required.
• Prefer 2yrs of manufacturing or pharmaceutical experience but not required.

Working Conditions / Physical Requirements:

• This position requires lifting (up to 50lbs), bending, climbing, reaching, good vision, standing, sitting, walking, gripping, talking, and hearing.