PCI Pharma Services ยท 1 day ago
Complaint and Investigation Engineer
Rockford, IL
Full-time
Onsite
Entry, Mid Level
$63K/yr - $71K/yr
1+ years expPCI Pharma Services is a global leader in providing life-changing therapies. The Complaints and Investigations Engineer is responsible for managing consumer complaints and deviations, analyzing processes, and driving improvements to enhance customer quality management.
BiotechnologyHealth CareLife ScienceMedical DevicePackaging ServicesPharmaceutical
Responsibilities
Primary customer contact responsible for receipt and logging of consumer complaints and product related investigations in EQMS
Responsible for maintaining complaint and investigation tracking systems
Verify validity of complaint information provided by customers
Communicate status of complaints and investigations at performance meetings
Compile information necessary to log for trending only complaints as well as complaints which require a formal response into the complaints system
Employ data driven tools and methodologies to perform root cause analysis when investigating complaint responses and deviations
Interpret technical specifications, product requirements and design concepts for components, assemblies, and products to identify opportunities and develop recommendations to improve product and process design
Write Deviation Notifications for complaints not caused by PCI
Enter, monitor, track, extend, and close complaint and investigation actions in EQMS
Populate, maintain and update priority lists utilized by organization and publish as needed
Populate, maintain and update various spreadsheets utilized for trending of products, defects, lines, etc
Compile data and generate complaint and investigation related metrics (prepare graphs and charts from various data sources)
Coordinate and maintain documents associated with complaints and investigations
Coordinate retain sample request, retrieval, inspection, and return
Filing and maintaining archived documents and returned complaint samples
Address and resolve quality events to solve problems and improve systems
Develop and implement corrective and preventative action plans
Document quality event resolution in a formal report
Function as a resource for statistical analysis
Support Quality Control in maintaining GMP compliance and system improvement
Support Customer audit activities
Evaluate statistical data as it pertains to investigation and complaint reports
Monitor and respond to customer questions/concerns
Complete Retain Only Review form as requested by the customer
This position may require overtime and/or weekend work
Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules
Attendance to work is an essential function of this position
Performs other duties as assigned by Manager/Supervisor
Qualification
Required
Bachelor's Degree in a related field and/or 1-3 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
Very High Reasoning: Ability to define problems, collect data, establish facts, and draw valid conclusions. Be able to interpret an extensive variety of technical instructions in math or diagram form and deal with several abstract/concrete variables
Preferred
Ability to adapt to changing work environments
High Standard of Report Writing
Benefits
Paid time off
Health insurance coverage (including dental and vision)
Flexible spending account
401(k) plan
Company
PCI Pharma Services
PCI Pharma Services is a provider of outsourced services to the global pharmaceutical market.
5001-10000 employees
H1B Sponsorship
PCI Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2021 (1)
2020 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2025-07-14Series Unknown
2020-08-24Acquired
2014-08-10Seed
Leadership Team
Gil Valadez
Chief Operating Officer
Recent News
2025-07-22
Company data provided by crunchbase