Packaging Group Lead, 2nd Shift na None

Job Summary

With advanced and specialized packaging knowledge, oversees and manages the daily operation of a packaging line.  Performs functions relating to the packaging of drug products consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP).   This role supervises the day-to-day activities of the Operators and provides guidance on tasks that are being performed on the line.  Often, this position is involved in the Operator interview process but are not decision makers in terms of hiring decisions, promotions, annual evaluations, etc.  This role is recognized as a process expert, and is qualified as a certified trainer and provides training to less senior Operators.  Proactively identifies and performs root cause analysis, in conjunction with other operators/technicians, makes recommendations, and aids in implementation.  Responsible for the safe and efficient execution of job duties, while ensuring product compliance to established standards.   

Oversees and coordinates packaging lines for single location.  May fill in for supervisor as necessary.

Responsibilities

Packaging Operations

• Coordinates each Operator’s responsibilities during each shift.
• Monitors the packaging process to ensure schedule is met within standards.
• Conducts final audit of Batch Records, including SAP transactions, prior to going to Packaging BR Reconciler; Is qualified and capable of running all packaging equipment across the entire packaging department.
• Conducts preliminary review of all daily Batch Production Record (BPR) for the line and logbook documentation to ensure detail and accuracy. 
• Accurately reviews BPR's steps for completeness and accuracy. 
• Request components, labels and inserts per the BPR.
• Set up packaging machinery; accurately sets equipment programming according to BPR's and SOP's.
• Conduct basic set ups, starts, operates, adjusts, troubleshoots and tears down packaging lines.
• Conduct sampling: Collects samples from each batch and submits to QA for retained samples.
• Executes procedures to complete tasks in a compliant and safe manner.

Equipment Cleaning

• Conducts verification of line/equipment cleaning and documents per SOP.
• Executes procedures used to clean pharmaceutical packaging equipment and facilities.
• Competently conducts Master Cleans and Line Clearances.

Continuous Improvement

• Captures and reports metrics; troubleshoots downtime in order to increase operational efficiency.
• Lead or participate in Continuous Improvement projects.
• Troubleshoots and resolves process issues.

Issues & Deviations

• Performs defect evaluations and initiates production event logs.
• Identifies, reports, and suggests resolutions for processing related issues.
• Assists in the investigation of unplanned deviations.

Quality

• Executes the required in-process product quality checks and documents accurately.

Teamwork and collaboration

• Communicates and coordinates change-overs and other equipment downtime issues to Reliability Technicians.
• Interfaces with supervisor and/or Quality personnel to inform of deviations or other line issues.

Continuous Training

• Is qualified as a certified trainer and provides training to less senior operators.
• Stays current on SOPs and cGMPs.

Continuous Safety & Compliance

• Contribute to safety audits.
• Carries out processing/packaging activities safely, as required, on a daily basis.  
• Follows all safety and compliance procedures and participates in required training.
• Adheres to all cGMP compliance/regulatory mandates and quality requirements.
• Participate in safety teams, start-up discussions, incident debriefs, etc.
• Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.

Misc

• Other related duties as assigned to meet departmental and Company objectives.

Qualifications

• High school diploma or equivalent.
• Minimum of 3 years of related packaging experience and/or proficiency demonstrated in competencies as required.

Knowledge

• Thorough knowledge of cGMP regulations and processes.
• Thorough knowledge of manufacturing and packaging operations.

Skills & Abilities

• Ability to oversee and manage the daily operation of a packaging line. 
• Qualified and capable of running all packaging equipment across the entire packaging department.
• Ability to monitors processes to ensure schedule is met within standards.
• Ability to conduct final audits of Batch Records, including SAP transactions, prior to going to Packaging BR Reconciler.
• Certified Trainer of others.
• Ability to analyze metrics and troubleshoot downtime in conjunction with other specialists.
• Effectively interfaces with Quality and supervisor to inform of deviations or other line issues.
• Demonstrates the ability to work in collaboration with others as a part of a team.
• Ability to lead or participate in Continuous Improvement projects.
• Good communication skills.
• Good attention to detail in order to conduct final audits and reviews.
• Ability to follow both verbal and written instructions including SOP’s and Batch Record documentation.
• Ability to accurately and precisely record data and batch information.
• Ability to work in both independent and team environments.
• Proficient in reading and writing English to understand work instructions and document results.

Physical Requirements

• Must be able to stand for long periods of time (8 or 12 hour shifts), lift at least 35 pounds, climb ladders, wear a dust mask or respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE, including safety glasses, ear plugs, and safety shoes.
• Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
• Vision - ability to see details at close range (within a few feet of the observer).
• Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.