What are the responsibilities and job description for the Quality Operations Supervisor 2 position at PCI Pharma Services?
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 Summary:
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:
1. Coordinates the daily activities of the QA Auditors.
2. Assists with the daily activities of Production Inspection personnel for packaging.
3. Implements inspection criteria and testing
4. Study and standardize departmental work practices to improve quality and efficiencies of subordinates.
5. Helps resolve quality related issues with other departments and customers.
6. 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.
7. Review records for accuracy of information, compliance with established procedures.
8. Reviews daily paperwork to assure all customer requirements and quality standards have been met and maintained
. 9. Promotes continuity of shifts through cooperation and communication within as well as with other departments.
10. Assist in the performance of monthly internal audits and any necessary corrective action to follow-up
11. Oversees Pest Control and Environmental (humidity, temperature, MKT) Monitoring Programs
12. Recommend and participate in disciplinary activities of subordinates.
13. Maintain testing equipment and supplies needed for the department
14. May assist in performing investigations, may write reports, memos, or letters.
15. This position may require overtime and/or weekend work.
16. Carries out essential functions of the Quality Operations Manager in his/her absence.
17. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
18. Attendance to work is an essential function of this position.
19. Perform Quality Health Check assessments to identify if processes and day to day activities are performed according to procedures.
20. Provides supervision/support to all sites at Rockford IL. (Plants 1, 2, 3, and 5).
21. Cross functional in the Incoming Quality Assurance department.
22. Manage, initiate and approve supplier non-conformances.
23. Performs other duties as assigned by Manager/Supervisor.
24. Carries out essential functions of the Quality Operations Manager in his/her absence.
Special Demands:
- Stationary Position: From 1/4 to 1/2 of the day.
- Move, Traverse: From 1/2 to 3/4 of the day.
- Operate, activate, use, prepare, inspect, or place: From 1/2 to 3/4 of the day.
- Install, place, adjust, apply, measure, use, or signal: From 1/2 to 3/4 of the day. - Ascend/Descend or Work Atop: From 1/4 to 1/2 of the day.
- Position self (to) or Move (about or to): From 1/2 to 3/4 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.
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 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 1/2 to 3/4 of the day.
* Work is primarily performed at a desk and/or in an office environment. for 3/4 of the day and up.
* Work near moving mechanical parts for 1/4 to 1/2 of the day. The noise level in the work environment is typically, moderate.
Qualifications:
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
Preferred:
- Ability to effectively present information to various people as the job requires. - Ability to work independently and/or part of a team.
- Ability to display a willingness to make decisions.
- Ability to display excellent time management skills.
Please note that you must be in your current position for a minimum of 6 months and in good standing to be eligible to apply for other internal positions.
Join us and be part of building the bridge between life changing therapies and patients.
LSNE is an EEO/AA Employer and all qualified applicants will receive consideration for employment without regard to, their race, color, religion, sex, age, national origin, ancestry, sexual orientation, gender identity, disability, protected genetic information, protected veteran status, military service, or other protected status. The Company’s EEO policy, as well as its affirmative action obligations, include the full and complete support of The Company.