at PCI Pharma Services Ohio, LLC in Rockford, Illinois, United States
Job Description
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.
Date Issued:
February 16, 2022
Application Deadline:
February 23, 2022
Wage Level:
Exempt
JOB DESCRIPTION:
Position Title: Quality Engineer Associate 1
Location: Assembly Drive
Department:
Shift: 1st
Reporting To: Quality Engineering Supervisor
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Overall responsibility of the Quality Engineer Associate I is to support the Consumer Complaints and Quality Engineering Team in maintaining GMP compliance and system improvement.
Primary customer contact responsible for receipt and logging of consumer complaints into Pilgrim and Daily Task List.
2. Responsible for maintaining complaints and deviations tracking system.
3. Correspond with customer regarding complaints and obtain additional information as needed.
4. Verify validity of complaint information provided by customers.
5. Communicate status of complaints and new complaints at performance meetings.
6. Compile information necessary to log for trending only complaints as well as complaints which require a formal response into the complaints system.
7. Close out complaints in Daily task list.
8. Write and investigate complaint responses.
9. Write Deviation Notifications for deviations or complaints not caused by PCI.
10. Complete non-confirmed deviations and be able to show proficiency in performing confirmed deviations while being mentored by a Level II.
11. Enter, monitor, track, extend, and close complaints, deviations, and CAPA information in Pilgrim.
12. Populate, maintain and update priority list utilized by organization and publish daily via e-mail.
13. Populate, maintain and update various spreadsheets utilized for trending of products, defects, lines, etc.
14. Compile data and generate complaints related metrics (prepare graphs and charts from various data sources).
15. Coordinate and maintain documents associated with complaints/deviations.
16. Coordinate documents request, retrieval, and return.
17. Coordinate retain sample request, retrieval, inspection, and return.
18. Filing and maintaining archived documents and complaint/deviations returned samples.
19. Monitor and respond to customer questions/concerns via the complaints inbox.
20. Assist in gathering information for complaints and deviations.
21. Complete Retain Only Review form as requested by the customer.
22. This position may require overtime and/or weekend work.
23. Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
24. Attendance to work is an essential function of this position
25. Performs other duties as assigned by Manager/Supervisor
Special Demands:
Stationary Position: From 1/2 to 3/4 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: Up to 1/4 of the day.
Position self (to) or Move (about or to): From 1/2 to 3/4 of the day.
Communicate or exchange information: From 1/4 to 1/2 of the day.
Detect, distinguish, or determine: From 1/4 to 1/2 of the day.
On an average day, the individual can expect to move and/or transport up to 25 pounds less than 1/4 of the day.
NOTE: Employees who have received a counseling report for a violation occurring within the last 3 months are not eligible to apply for open positions
QUALIFICATIONS:
Required:
- High School Diploma or GED and/or 1-3 years related experience and/or training.
- Basic Mathematical Skills
- Basic Computer Skills: Ability to perform basic computer tasks and has the ability to operate common computer programs.
- Full Professional Proficiency: Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.
- Intermediate Reasoning: Ability to apply common sense understanding to carry out instructions that may be furnished in written, oral, or diagram form. Ability to deal with problems that involve several concrete variables in standardized situations.
- High Standard of Report Writing
Preferred
- Ability to demonstrate attention to... For full info follow application link.
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.
