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Date Issued:

February 9, 2022

Application Deadline:

February 16, 2022

Wage Level:

Hourly

JOB DESCRIPTION:

Position Title: Operations Team Lead

Location: Assembly Drive, Rockford, IL 61109

Department: 1041 (Operations)

Shift: 2nd Shift

Reporting To: Supervisor, Production

Responsible For (Staff): None

This position is responsible for supporting the coordination of production activities under the guidance of the production supervisors. This includes meeting targeted objectives in the areas of safety, quality and compliance, service, OEE, communication, continuous improvement, and waste control of the value stream to which they are assigned.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Ensure that all Line Leaders and packers on their lines are trained and in strict compliance with Batch Records and applicable safety and quality procedures and regulations. Will help oversee people in training and may assist in the certification of Operators.
• Leads the production team to ensure that throughput is maximized, while sustaining safety, quality, and adherence to the weekly schedule. This will include assisting with challenges as needed and insuring strict enforcement of challenges, in process testing, sign in/set up and all critical process steps.
• Assist Production Supervisor in labor management per established standards. Make sure their teams track time accurately and swipe in and out of work orders and indirect activities. Will also make sure that Factory MES is used as expected each day.
• Assist the Supervisor in the placement of personnel on the production lines to promote achieving daily goals while effectively cross training and rotating personnel.
• Responsible for ensuring adherence to the production schedule. Ensure line speed is set at the optimum rate. Identify and resolve quality defects, machine efficiency losses, material problems, etc. Ensure raw materials are adequately stocked on the production line
• Will prepare the next order prior to lot change to insure the changeover is prepared for the team that is approaching lot change. Will make sure teams check all incoming components against batch record to verify they are correct. Will prepare serialization orders to insure the next lot is ready. Will sign as Supervisor designee where allowed in batch records. Will drive lot in activities within the value stream assigned.
• Will assist in lot out activities. This will include investigating accountability issues, serialization lot out and lot in activities, equipment staging and moving, equipment preparation for new layout, etc. Will prepare and drive lot out activity in the value stream assigned.
• Communicates line activity to the Production Supervisor and the rest of the team.
• Promotes and maintains a safe work place. Supports 5S throughout the facility. Maintains work area in a neat and orderly manner. Ensure compliance to company policies, cGMP's and SOP's. Maintain high levels of cGMP compliance and expects that all 5s principles are followed including material flow and min/max expectations. Ensure 5s audits are conducted and results shared.
• Leads work teams within their Value Stream that will produce quality products, high efficiencies as well as foster a work environment that has meaning, direction, purpose and fulfillment for our Associates. In conjunction with the Supervisor will appropriately addresses performance and/or job related behavior issues.
• Provide leadership in Safety, Quality, and Service through the use of continuous improvement in their assigned value stream. Ensure all line personnel perform their jobs in a safe manner complying with company safety standards and rules. Take immediate corrective action when necessary. Will participate in Safety and Quality RIT's as needed in support of continuous improvement.
• Provide productive direction to line personnel during equipment downtime, and verify labor is being utilized to the work order. Assist in lack of work activities. When lines are not able to run production, the lead will assist supervisor in communicating who will need to redeployed to another line or sent home.
• Able to perform machine operator functions when required. Assist line personnel when necessary to maximize line performance.
• Ensure all team members are trained to perform the job function for which they are assigned and have signed off on the most current procedures. Ensure all team members can effectively perform all necessary product assembly, quality, safety, and material control functions including accurate preparation of daily reports. Will support the Supervisor in cross training efforts.
• Ensure the accurate completion of required documentation and per prescribed SOP's and cGMP's including a review of accuracy prior to submitting to QA. Will coach team members on errors and work with the Supervisor to improve Batch Record accuracy.
• Provide support in the documentation of production results and shift performance including the collection of waste numbers.
• Lead and facilitate line level daily direction setting meetings to effectively plan for the next 24 hours and assign owners to address improvement opportunities in order to more effectively achieve daily production goals. Coach and train Line Leaders and PRT's to lead these meetings.
• This position may require overtime and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by Manager/Supervisor.

Special Demands:

• Stationary Position: Under a 1/4 of the day.
• Move, Traverse: 3/4 of the day and up.
• Operate, activate, use, prepare, inspect, or place: From 1/4 to 1/2 of the day.
• Install, place, adjust, apply, measure, use, or signal: Up to 1/4 of the day.
• Ascend/Descend or Work Atop: Up to 1/4 of the day.
• Position self (to) or Move (about or to): Up to 1/4 of the day.
• Communicate or exchange information: 3/4 of the day and up.
• Detect, distinguish, or determine: 3/4 of the day and up.

On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day.

NOTE: Employees who have received a counseling report for a violation occurring within the last 3 months are not eligible to apply for open positions

QUALIFICATIONS:

Required:

• Skill testing requirements met at approved grade level for position.
• Basic Mathematical Skills
• Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
• Minimum Professional Proficiency: Ability to speak in a way that allows one to participate effectively in various conversations. Ability to read various types of standard items addressed to general readers.
• Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
• High School Diploma and/or 3-5 years related experience and/or training.

Preferred:

• Ability to demonstrate attention to detail.
• Ability to adapt to a changing work environment.
• Ability to follow instructions and respond to management direction.

Equal Opportunity Employer/Vet/Disabled

Join us and be part of building the bridge between life changing therapies and patients.

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.