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Quality Control Production Equipment

Location:
Augusta, GA
Posted:
July 11, 2023

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Resume:

BARRON SULLIVAN

**** ********* **.

Augusta, GA *0909

Home # 706-***-**** Cell # 706-***-****

adx8h8@r.postjobfree.com

Career Profile

Qualified Production Supervisor with 10 years of Manufacturing Management Experience including cross-training and scheduling employees, ordering parts, data keeping and meeting all production deadlines. Dedicated Leader with demonstrated ability to train, manage and motivate team members to achieve organizational objectives.

Skills and Highlights

Experienced in Production Scheduling

Process Certification

Certified in (RO) Reverse Osmosis

Dedicated to Production Quality

Emergency Response Team Captain (ERT)

Knowledge of cGMP manufacturing

Commissioning and Validation

Good computer skills, knowledge of Microsoft Word and Excel.

Ability to apply quantitative analysis to analyze process performance.

Start -up operations

cGMP’s

Professional Experience

Unit Specialist Manufacturing April 2022- Current Date

Execute floor and console tasks, investigate alarms, and make required adjustments in the process areas.

Operate in a safe and compliant manner and follow all applicable Safety and Quality SOPs and regulations.

Troubleshoot equipment or conditions, make recommendations to the Process Engineers, Maintenance Engineer, or Manager, and implement changes to achieve efficient operating conditions.

Complete all required documentation accurately and legibly under FDA and cGMP specifications.

Perform minor preventive, predictive and corrective maintenance on area equipment.

Train, mentor, and develop other operators on standard operating procedures and good manufacturing practices.

Perform general housekeeping/sanitizations in assigned areas to keep clean and maintain a state of control.

Work in a team-based environment, willing to participate in team activities, serve in leadership roles and be receptive to receiving and giving constructive coaching to team members and management.

Follow good aseptic practices and techniques when required for quality assurance.

Identify safety hazards, issue permits and perform lock out/tag out of equipment when required.

Catalent Pharmaceutical Solutions Harmans, MD Jan 2021-September 2021

Planner / Scheduler

Interact with manufacturing leadership to ensure an accurate weekly manufacturing schedule by driving the necessary timeline/deadline for completion.

Identifying areas for continuous improvement on scheduling method, delivery times, cost, and quality.

Generate and maintain comprehensive manufacturing schedule for biologic drug manufacturing processes including upstream, downstream, fill-finish and central services activities.

Interact with leaders from each of the process areas to receive scheduling inputs via email. The data used for the schedule will transition to ERP system.

Update schedule with real time updates daily and weekly

Collaborate with functional leadership outside of GMP Manufacturing to schedule the manufacturing areas for cleaning, shutdown, repairs, maintenance, calibrations, among other activities.

Hold scheduling meetings with Planning to determine necessary changes to the plant's production schedule.

Key contact for orchestrating PMs and Cals within Manufacturing and hold meetings to facilitate planning action follow up and key recovery activities.

Takeda (formerly Shire Inc.) Covington, GA Nov 2017 – Jan 2021

Manufacturing Lead (Monitoring Tech) - Fractionation

Monitor and update production process schedules in real-time. Escalate delays in a timely manner.

Redirection of planned production activities as required.

Evaluate cleaning of equipment and parts for process use.

Coordination of activity planning with maintenance, metrology, technical services, and other departments.

Oversee the process of scheduling, ensuring completion and maintaining log book for Sanitizations

Responsible for resolving any discrepancies between JDE and EBM material transactions.

Financial closure and status update of process work orders and maintenance work orders.

Assists in cycle counts and variance reporting.

Involved in specific production processes, she/he may problem solve in other functional areas.

Cross trains and assists with back up when necessary.

Must communicate daily activities, issues and solutions effectively using verbal and electronic means.

Assist Manufacturing and Quality departments in CAPA investigations

Complies with SOPs, GMPs, safety rules and regulations, and departmental procedures.

Provides leadership to enhance performance of department and take charge in the absence of the supervisor/Manufacturing Lead.

Shire (formerly Baxalta Inc.) Covington, GA April 2016 – Nov 2017

Manufacturing Associate III, Fractionation

Performed commissioning and qualification activities of several manufacturing areas.

Involved in hands-on execution of manufacturing operations and provide troubleshooting.

Trained and explained processes to others and ensured execution of processes in commissioning while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply.

Prepare media and buffer solutions

Operate Clean-in-Place (CIP) and Clean-in-Place systems (COP)

Assemble and operate filtration systems

Operate general production equipment (such as pH and conductivity meters, autoclave, portable mixers, etc)

Monitor and record critical process parameters

Complete all relevant paperwork following GDP/GMP guidelines

Perform routine maintenance and cleaning of production equipment to maintain in GMP fashion

Perform sampling using aseptic techniques

Participate on Continuous Improvement Teams

Write, revise and review pertinent documentation as appropriate

Assist with process/equipment validation and data analysis

Contribute toward authoring SOP’s and Job Aids, associated with manufacturing processes

Support a perfect equipment culture by assisting maintenance team during implementation of program such as Total Preventive Maintenance (TPM), and Equipment Reliability, Preventive Maintenance (PM) Predictive Maintenance (PDM) programs etc.

DSM Chemicals Augusta, GA February 2015 – January 2016

Area Process Operator

Monitor process unit and quality control testing performance for plant and water quality sampling.

Ran and washed filtration process units. Good knowledge of pumps, agitators, MBV and vessels.

Make sound and logical judgments regarding process changes.

Closely inspect equipment for safety issues leaks and wear and tear.

Start up and shut down water and waste water treatment process.

Communicate effectively with operators and supervisors on technical level.

NutraSweet Augusta, GA January 2010 – December 2015

Finish Product Supervisor

Supervise production schedules, production quality and on time delivery.

Coordinate closely with Quality Control regarding product awaiting dispositions.

Establish and adjust work procedures to meet production schedules.

Define manufacturing performance standards and review the performance outcome to set future targets.

Coordinate preventable maintenance on existing and new production equipment, including routine calibrations.

Operates all equipment throughout Manufacturing Process to back-fill. Diligently maintain Safety and Quality Standards, improve efficiency and production by eliminating waste and production constraints.

Maintain and enforce a safe and clean working environment.

NutraSweet Augusta, GA January 2008 – January 2010

Chemical Operator (RO)

Monitor process unit and quality control testing performance for plant and water quality sampling. Ran and washed filtration process units.

Good knowledge of pumps, agitators, MBV and vessels.

Make sound and logical judgments regarding process changes.

Closely inspect equipment for safety issues leaks and wear and tear.

Start up and shut down water and waste water treatment process.

Communicate effectively with operators and supervisors on technical level.

Club Car Augusta, GA December 1988 – September 2007

Crew Leader

Diligently maintain Safety and Quality Standards.

Coordinate and develop new production design in collaboration with engineering staff.

Define manufacturing performance standards and review the performance outcome to set future targets.

Implement Root Cause and Corrective Action to remove production constraints

Collaborate with engineering team to adjust and modify production equipment.

Review production order, schedules, delivery dates and inventory levels to determine product availability.

Train, develop and counsel employees to develop a high performance team.

Complete key projects on time, on budget and with high level of accuracy.

Coach employees in developing and achieving individual performance goals.

Develop and maintain strong and clear communication and rapport with plant personnel.

Education

Augusta Technical College, Augusta GA.

Certificate in Chemical Operations Technology 2002 – 2004

Associates Degree in Cyber Security

2015 – in progress



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