Complaint and Investigation Engineer

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.

Summary of Objective:

Summary

Overall responsibility of the Complaints and Investigations Engineer is to compile information pertaining to consumer complaints and deviations and analyze the systems, processes and procedures to properly respond to the reported and identified defects or issues.  This position helps drive project success and identify improvements to provide PCI a competitive advantage in long-term quality customer management.

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.

• 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

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 1-3 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

The hiring rate for this position is $62,960-$70,830 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.