Commercial Complaints Associate I

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:

Overall responsibility of the Quality Engineer Associate I is to support the Consumer Complaints, Quality Engineering, and Computer System Validation Team in maintaining GMP compliance and system improvement.

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 into Pilgrim and Daily Task List.

• Responsible for maintaining complaints and investigations tracking system.

• Correspond with customer regarding complaints and to obtain additional information as needed.

• Verify validity of complaint information provided by customers. Communicate status of complaints and new complaints at daily performance meeting.

• Compile information necessary to log for trending complaints as well as complaints which require a formal response into the complaints system.

• Compile information necessary to log for investigations and quality events into the Pilgrim system for shared services.

• Close out complaints in Daily task list. Write and investigate Level I (not cause by PCI, dispensability, efficacy etc.) complaint responses.

• Enter, monitor, track, extend, and close complaint responses, investigations, and CAPA information in Pilgrim.

• Populate, maintain and update priority listed utilized by organization and publish daily via e-mail.

• Populate, maintain and update various spreadsheets utilized for trending of products, defects, lines, etc.

• Assist Computer Validation Supervisor by routing validation documents in pilgrim.

• Assist with computer system periodic reviews. Assist with executing computer system validation test scripts.

• Compile data and generate complaints related metrics (prepare graphs and charts from various data sources).

• Coordinate and maintain documents associated with complaints and investigations.

• Coordinate documents request, retrieval, and return.

• Coordinate retain sample request, retrieval, inspection, and return.

• Filing and maintaining archived documents and complaints returned samples.

• File and maintain Line Clearance failures (AP38) retains samples.

• Monitor and respond to customer questions/concerns via the complaints inbox.

• Assist in gathering information for complaints and investigations.

• Assist in investigating consumer complaints and complete complaint responses.

• 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:

• Associate's Degree in a related field 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 detail.

• Ability to exhibit sound and accurate judgment.

• Ability to follow instructions and respond to management direction.

• Ability to identify and resolve problems in a timely manner.

• 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.

The hiring range for this position is $19.96 - $22.46/hour 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), flexible spending account, and 401(k).

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.