Packaging Manager

Department

Packaging

Job Title

Manager

FLSA Status

Exempt

Reports To

Director of Operations

1.    Role Purpose:

The Packaging Manager will Lead, Train, and Direct the daily activities of the Packaging Departments while collaborating with customer service to meet business needs, while following all applicable Standard Operating Procedures/cGMP’s, as well as maintain a safe work environment.

2.    Key Duties & Responsibilities:

• Supervise and manage day to day operations of Packaging.
• Develop and adhere to daily planning and scheduling to ensure proper workflow.
• Monitor, organize, and execute all functions associated with packaging of pharmaceutical commercial products ANDA batches, while assuring compliance with cGMP, SOP, FDA, DEA, and OSHA rules and regulations.
• Work directly with management and group leaders to ensure appropriate follow-through of the weekly planning schedule, including Manufacturing, Quality Assurance, Shipping and Sales.
• Report shift completions and weekly planning schedule.
• Responsible for accuracy and completion of packaging batch records and all paperwork in a timely manner.
• Motivate a diverse workforce and demonstrate the ability to interact effectively with employees, to exceed department goals, which include safety, compliance, quality, and productivity.
• Assist in the completion of Packaging Investigations as needed.
• Ability to communicate effectively both orally and in writing as pertains to planning, assigning and supervising the work of staff and providing status reports to management to increase efficiencies across department.
• Communicate changes in schedule to the staff and provide feedback of Packaging activities during Quality Council and weekly Operations strategy meetings.
• Train on SOP’s, new processes, safety, ALCOA+, GxP and cGMP’s on a continuum.This also includes ensuring mechanics are properly trained to minimize downtime and  group leaders and other packaging employees can aid in the set up packaging equipment.
• Collaborate with HR and Senior management to assess staffing levels and approve increases and decreases.
• Comply with FDA guidelines and Company Policies.
• Other duties, as assigned.

3.    Typical Supervisory Responsibility:

Supervise the day-to-day activities of packaging operators, group leaders, material handlers and mechanics on one shift in a pharmaceutical packaging environment to ensure that packaging lines are run in an efficient manner, company packaging and shipping schedules are met and waste and downtime are minimized.

4.    Education & Experience:

Education Requirement

Bachelor’s degree preferred

Experience Requirement

Number of Years

1-3 years previous experience working in a regulated environment

5.    Technical competencies/ Certifications/ Licenses:

Technical competencies

• 1-3 years previous experience working in a regulated environment (GMP or FDA) or a combination of work experience and college or technical school education preferred.
• Working knowledge of Microsoft Office.
• Basic knowledge of an Inventory reporting system, e.g., SYSPRO, JDE, SAP, Vantage.
• Must have good communication skills, both written and oral.
• Must be able to read, write, and communicate in English.
• Knowledge of principles, policies, practices, procedures, and strategies required to properly supervise and perform the operations of packaging lines.
• Technical background in the fields of packaging equipment installation operations (IQ/OQ/PQ) and preventative maintenance.
• Monitor Production losses and overall.
• Productivity, suggest enhancements to increase productivity.
• Must have leadership skills.
• Accuracy reporting to ERP System (SYSPRO).
• Accuracy reporting to batch records.
• Entering information in log books for DEA, and FDA purposes.
• Must be a critical thinker with a “can do” attitude, and be able to think “outside the box”.
• Process troubleshooting across all shifts.
• Ability to maintain good housekeeping across various Suites in a GMP environment.
• Thorough understanding of IQ, OQ, and PQ.
• Handle and complete special projects as required.
• Other duties as required or delegated.
• Document all information as per cGMP, USFDA and 21CFR211.194 guidelines.
• Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.
• Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
• Follow all DEA (Drug Enforcement Agency) guidelines.

6.    Physical demand and Work environment:

a.    Physical demands:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear.  The employee must lift and/or move up to 20 pounds.  Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

b.    Work environment:

N/A