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Job Title: Lead, Quality Operations

Department/Group: Quality Operations

Location: New Milford School Road

Shift: 2nd (10hrs)

Summary of Objective:

Provides direction to other team members by ensuring they have signed the roster, completed the appropriate inspections; assigning team members to the appropriate lines / tasks; ensuring Auditors and Inspectors have the necessary knowledge to perform job functions; and assisting Auditors and Inspectors with questions or issues.

Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

Responsible to lead the Quality Operations auditing team (Quality Inspector/Auditor), ensuring team goals are on track. Communicates important information such as quality and team performance issues to the Quality and Operations Supervisor and or Quality Operations Manager. Complete the End of Shift Notes and communicates any Quality issues/topics to the next shift. Completes and or corrects necessary documentation such as batch record entries. Performs scheduling activities for the shifts by staffing the lines; reassigning the team based on production demands; managing and or backfilling the Quality Inspector/Auditor role. Supports the production floor by answering any questions related to Quality. Supports and assists the Quality Inspectors/Auditors in the day to day activities. Assists Supervisors by completing or reviewing paperwork; attending or leading meetings when necessary; and training new employees on the liens, SOPs, and cGMP. Assists in the hiring of agency employees by interacting with the temporary employment agency and Human Resources; submitting results to the appropriate individuals and departments (e.g., Training, Quality); and training agency employees. This position may require overtime and/or weekend work. Makes good sound judgement to resolve any quality matters. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Perform Quality Health Check assessments to identify if processes and day to day activities are performed according to procedures. Performs other duties as assigned by Manager/Supervisor. Initiates Product / Process Deviations. Distribute Quality Event Notifications. Obtains documents from the EDMS. Initiate Change Requests for Batch Records.

Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions

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

This position may have the following special vision requirements.

• Close Vision ☒ Distance Vision ☒ Color Vision ☒ Peripheral Vision ☒ Depth Perception
• Ability to focus ☐ No Special Vision Requirements

Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

The following are some environmental conditions that one may be exposed to on a daily basis and for various lengths of time.

• Work is performed in areas with moderate risk or discomfort that may require special safety precautions, such as wearing protective clothing or gear for 3/4 of the day and up.
• Work is primarily performed at a desk and/or in an office environment. for up to 1/4 of the day.
• Work near moving mechanical parts for 3/4 of the day and up.
• Work in high, precarious places for up to 1/4 of the day.

The noise level in the work environment is typically, moderate.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Required:

• Skills 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.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• High School Diploma or GED and/or 3-5 years related experience or training.

Preferred:

• Ability to effectively present information to various people as the job requires.
• Ability to identify and resolve problems in a timely manner.
• Ability to display excellent time management skills.
• Ability to display a willingness to make decisions.

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