Supervisor, Quality Operations

Rockford, IL, USA

Full time

JR120106

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

** We are PCI.*
* Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

Job Title:

Supervisor, Quality Operations

Department/Group:  
** Quality Operations*
* Location:

** Assembly*
* ** Summary of Objective:*
* 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.

*
* 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.

+ Coordinates the daily activities of the QA Auditors.

+ Assists with the daily activities of Production Inspection personnel for packaging.

+ Implements inspection criteria and testing Study and standardizes 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.

+ 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 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 .

+ May assist in performing investigations, may write reports, memos, or letters. 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.

+ 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.

*
* 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:

*
* + Bachelor's Degree in a related field and/or 1-5 years related experience and/or training.

+ College Level 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.

+ High Standard of Report Writing

**…