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.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
The 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.
Responsible for maintaining complaints and deviations tracking system.
Correspond with customers regarding complaints and obtain additional information as needed.
Verify the validity of complaint information provided by customers.
Communicate the status of complaints and new complaints at performance meetings.
Compile information necessary to log trending-only complaints as well as complaints that require a formal response into the complaints system.
Close out complaints in the Daily task list.
Write and investigate complaint responses.
Write Deviation Notifications for deviations or complaints not caused by PCI.
Complete non-confirmed deviations and be able to show proficiency in performing confirmed deviations while being mentored by a Level II.
Enter, monitor, track, extend, and close complaints, deviations, and CAPA information in Pilgrim.
Populate, maintain, and update the priority list utilized by the organization and publish daily via e-mail.
Populate, maintain, and update various spreadsheets utilized for trending products, defects, lines, etc.
Compile data and generate complaints-related metrics (prepare graphs and charts from various data sources).
Coordinate and maintain documents associated with complaints/deviations.
Coordinate documents request, retrieval, and return.
Coordinate retain sample request, retrieval, inspection, and return.
Filing and maintaining archived documents and complaint/deviations returned samples.
Monitor and respond to customer questions/concerns via the complaints inbox.
Assist in gathering information for complaints and deviations.
Complete the 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, and rules.
Attendance to work is an essential function of this position
Performs other duties as assigned by the Manager/Supervisor
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 can 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
Associate degree in Science is highly preferred.
Ability to demonstrate attention to detail.
Ability to exhibit sound and accurate judgment.
Ability to follow instructions and respond to management direction.
Ability to identify and resolve problems promptly.
Ability to display excellent time management skills.
Ability to adapt to changing work environments.
Ability to work independently and/or as part of a team.
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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, Diversity, Equity, and Inclusion (DEI) 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.