Commercial Quality Lead

Commercial Quality Lead

$22.15-$23.00 per hour

Lead a high-impact Quality Operations team in a fast-paced pharmaceutical manufacturing environment where quality, compliance, and teamwork drive success. In this role, you'll oversee daily auditing operations, support production excellence, mentor Quality Inspectors and Auditors, and help ensure cGMP and GCP standards are met at every stage. We're looking for a proactive leader with strong problem-solving skills, sound judgment, and a passion for continuous improvement who thrives in a collaborative, hands-on environment.

Commercial Quality Lead Responsibilities Include But Are Not Limited To:

• 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 communicate 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.

Commercial Quality Lead Requirements:

- Skills testing requirements met at approved grade level for position. - Basic mathematical skills. - Ability to perform basic computer tasks and has the ability to operate common computer programs. - 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. - 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. - Ability to effectively present information to various people as the job requires preferred. - Ability to identify and resolve problems in a timely manner preferred. - Ability to display excellent time management skills preferred. - Ability to display a willingness to make decisions preferred. - 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.