Supervisor, Clinical Quality

PCI Pharma Services•Rockford, IL

8d•Onsite

About The Position

This role determines and maintains quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures and customer requirements. Provides resolution to quality deviations/issues and recommends solutions based on SOP/cGMP requirements. Coordinates and assists with the daily activities of Quality Inspectors for packaging. Implements inspection criteria and testing, and reviews/approves batch record documents through MasterControl. This position may require overtime and/or weekend work. Carries out essential functions of the Quality Operations Manager in his/her absence. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules. Attendance to work is an essential function of this position. Performs 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.

Requirements

Bachelor's Degree in a related field and/or 1-3 years related experience and/or training.
Basic Mathematical Skills
Intermediate Computer Skills: Ability to perform more complex computer tasks and has knowledge of various computer programs.
Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
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.
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
Attendance to work is an essential function of this position.

Nice To Haves

Ability to demonstrate attention to detail.
Ability to exhibit sound and judgment.
Ability to work independently and/or as part of a team.

Responsibilities

Determines and maintains quality standards developed in compliance with current Good Manufacturing Practices, the Company's own Standard Operating Procedures and customer requirements.
Provides resolution to quality deviations / issues.
Recommends solutions based on SOP / cGMP requirements.
Coordinates the daily activities of the Quality Inspectors.
Assists with the daily activities of Quality Inspection personnel for packaging.
Implements inspection criteria and testing and reviews/approves batch record documents through MasterControl.
Study and standardize departmental work practices to improve quality and efficiencies of subordinates.
Helps resolve quality related issues with other departments and customers.
Motivates, develops and provides continuous training either through the use of departmental work instructions, examination of cGMP's and SOP's, specific customer requirements or by personal instruction.
Prepare periodic and special reports concerning departmental activities, problems, quality systems, schedules, etc.
Review records for accuracy of information, compliance with established procedures.
Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained.
Promotes continuity of shifts through cooperation and communication within as well as with other departments.
Assist in the performance of monthly internal audits and any necessary corrective action to follow-up.
Responsible for overseeing quality improvement processes related to receiving inspection.
Oversees Pest Control and Environmental (humidity, temperature, MKT) Monitoring Programs.
May disposition NMR's.
Recommend and participate in disciplinary activities of subordinates.
Maintain testing equipment and supplies needed for the department.
Trouble-shoot special equipment and software utilized during quality inspections.
Completes and assists in performing investigations, and writing reports, memos, or letters.
Carries out essential functions of the Quality Operations Manager in his/her absence.
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.