Packager - Support Specialist - Abacus : Job Details

Description: Packager - Support Specialist Important that they are able to work on the 1st shift (6:45 a.m. - 3:30 p.m.) for 4 weeks to train. Then they will be assigned to the 2nd shift (3 p.m. - 11:45 p.m.) or the 3rd shift (10:30 p.m.- 7:15 p.m.) depending on their availability. There is a 45-minute lunch and two 15-minute breaks. Job Purpose Responsible for releasing and controlling production lines, ensuring production line staff are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all batches. Major Accountabilities • Provides direction/line assignments to packaging personnel. • Starts up production lines at the beginning of the shift and at the start of batches to release lines. • Monitors lines including correct weights, lot number, expiration date and scans in drums of product. • Calculates and documents in Filling Instructions tare weights for each packaging component number. • Reviews batch paperwork for accuracy and issues to the batch records clerk. • Checks and prepares paperwork for upcoming batches. • Sets up and monitors cleaning and filling Validation batches according to protocols. • Accepts and controls labels for individual orders. Counts and verifies labeling, packaging components and finished product against pick list, material list report, and palletizing pattern. • Processes paperwork for Labeling Returns and brings returns to the Label Room or the Batch Clerks Office. • Verifies correctness of components and product per the Filling Instructions. • Prints pallet tickets and quarantine tags on finished product skids. • Enters counts electronically or in pallet book and documents line status in logbooks. • Performs line clearances, counts and documents returns to stock. • Performs SAP transactions such as Return to Stock (RTS) or paper transfer using scanning guns. • Sets up electronic marquees indicating the product information for production lines. • May calibrate scales/checkweighers daily or when moved to new locations on the production floor. • Checks all cleaned parts on the production line. • Responsible for Daily Packaging Thruput/Changeover, and Labor tracking reports. • Provides feedback on operator performance. • Interacts with production management, mechanics, and Quality Assurance. • Participates in training of new employees. • Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals. Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA. Key Performance Indicators • Identifies efficiency, quality, safety and equipment issues and provides corrective actions. • Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, MI's/FI's, and production equipment cleaning instructions. • Basic mathematical skills and ability to work with numbers to determine reconciliation, product yield, potency calculations and waste. • Ability to present information to employees, coordinate activities, prioritize workload, make routine business decisions as it affects personnel, production goals, schedule attainment and planning ahead. • Work on projects independently or in a team environment, actively participate on teams ex. (BBS/ IQP), • Perform key roles in a manner which motivates personnel, promotes teamwork, is respectful of others and is aligned with Sandoz's behaviour expectations. • Takes initiative and works autonomously to meet production requirements. • Participates in Behavioural Based Safety Program (BBSP) by complying with and assuring personnel are following all safety procedures (LOTO) and preventive measures (i.e., wearing Personal Protective Equipment (PPE), following lockout/tagout procedures). • Continues to develop and learn new skills which will allow for further advancement within the organization. Job Dimensions Number of associates: 0 Impact on the organization: Low Ideal Background Education: • High School Diploma or GED Experience: • At least two years experience in filling and packaging of pharmaceutical products. • Basic knowledge of computer applications, including SHAPE system and Microsoft Office. • Proficient in basic level arithmetic. Working knowledge of metric system. • Ability to lift up to thirty pounds, to stand, walk or sit over extended periods of time, and to maintain a high level of activity, as well as the use of a pallet jack. • Knowledge of cGMP and SOP procedures for filling and packaging of pharmaceutical products Enable Skills-Based Hiring No Hours per Day 8 Hours per Week 40 Total Hours 6,240.00 Attachment: ROLE PROFILE General (organization chart to be attached) Job Title: Department: Reports to (Job Title): Packager - Support Specialist Packaging P ckaging Operations - Supervisor/Manager Job Purpose Responsible for releasing and controlling production lines, ensuring production line staff are operating the lines and handling the material/equipment according to product specifications, reviewing batch paperwork, performing line clearances, setting up and monitoring all batches. Major Accountabilities

• Provides direction/line assignments to packaging personnel.
• Starts up production lines at the beginning of the shift and at the start of batches to release lines.
• Monitors lines including correct weights, lot number, expiration date and scans in drums of product.
• Calculates and documents in Filling Instructions tare weights for each packaging component number.
• Reviews batch paperwork for accuracy and issues to the batch records clerk.
• Checks and prepares paperwork for upcoming batches.
• Sets up and monitors cleaning and filling Validation batches according to protocols.
• Accepts and controls labels for individual orders. Counts and verifies labeling, packaging components and finished product against pick list, material list report, and palletizing pattern.
• Processes paperwork for Labeling Returns and brings returns to the Label Room or the Batch Clerks Office.
• Verifies correctness of components and product per the Filling Instructions.
• Prints pallet tickets and quarantine tags on finished product skids.
• Enters counts electronically or in pallet book and documents line status in logbooks.
• Performs line clearances, counts and documents returns to stock.
• Performs SAP transactions such as Return to Stock (RTS) or paper transfer using scanning guns.
• Sets up electronic marquees indicating the product information for production lines.
• May calibrate scales/checkweighers daily or when moved to new locations on the production floor.
• Checks all cleaned parts on the production line.
• Responsible for Daily Packaging Thruput/Changeover, and Labor tracking reports.
• Provides feedback on operator performance.
• Interacts with production management, mechanics, and Quality Assurance.
• Participates in training of new employees.

• Adheres to all applicable procedures, cGMP's, company policies, and all other quality or regulatory requirements (OSHA, DEA, FDA, EMEA, ANVISA, HS&E, etc.). Ensures all work is performed in a safe, effective manner, and in compliance with the appropriate industry and regulatory (FDA, DEA, OSHA) standards, and Departmental, Plant, and Corporate quality and Behavioral Based Safety (BBS) goals.

Note: This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained under OSHA's HAZWOPER standard, 29 CFR 1910.120 as an 8-Hour first responder, 24-Hour incident commander, or a 40-Hour incident commander. In lieu of HAZWOPER training, the employee will receive training on the requirements of the Resource Conservation and Recovery Act pursuant to 40 CFR 265.16. All employees that have received the above-mentioned training upon hire will receive annual refresher training that covers the OSHA HAZWOPER standard and the requirements of RCRA. Key Performance Indicators

• Identifies efficiency, quality, safety and equipment issues and provides corrective actions.
• Solid English reading/comprehension written and verbal communication skills required to understand and communicate to others detailed cGMPs, SOP's, MI's/FI's, and production equipment cleaning instructions.
• Basic mathematical skills and ability to work with numbers to determine reconciliation, product yield, potency calculations and waste.
• Ability to present information to employees, coordinate activities, prioritize workload, make routine business decisions as it affects personnel, production goals, schedule attainment and planning ahead.
• Work on projects independently or in a team environment, actively participate on teams ex. (BBS/ IQP),
• Perform key roles in a manner which motivates personnel, promotes teamwork, is respectful of others and is aligned with Sandoz's behaviour expectations.
• Takes initiative and works autonomously to meet production requirements.
• Participates in Behavioural Based Safety Program (BBSP) by complying with and assuring personnel are following all safety procedures (LOTO) and preventive measures (i.e., wearing Personal Protective Equipment (PPE), following lockout/tagout procedures).
• Continues to develop and learn new skills which will allow for further advancement within the organization.

Job Dimensions Number of associates: 0 Impact on the organization: Low Ideal Background Education:

• High School Diploma or GED

Experience:

• At least two years experience in filling and packaging of pharmaceutical products.
• Basic knowledge of computer applications, including SHAPE system and Microsoft Office.
• Proficient in basic level arithmetic. Working knowledge of metric system.
• Ability to lift up to thirty pounds, to stand, walk or sit over extended periods of time, and to maintain a high level of activity, as well as the use of a pallet jack.
• Knowledge of cGMP and SOP procedures for filling and packaging of pharmaceutical products

Approvals (Print Name & Signature) Employee : Date: Manager: Date: P&O Representative: Date: