Clinical Quality Specialist

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.

Responsible for the daily maintenance and oversight of the Electronic Quality Management System (eQMS) for the Clinical Quality group, ensuring timely and proper logging of Events, Deviations and Customer Complaints. Responsible for ensuring CAPA's effectiveness and timeliness. Maintains required Quality Metrics (Documents, Investigations, and CAPA's) on a routine basis. Develop, write, revise and review clinical work practices, and forms in accordance with PCI and GMP requirements as requested. Verify changes adhere with SOP's, WP's and customer requirements. May perform required regulatory functions of document control such as clinical document issuance, review and retrieval. May prepare clinical master files. Create and maintain clinical documents in accordance with cGMP's.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Log, monitor, track, extend, and close events, complaints, deviations, action items and CAPA information in the Master Control eQMS.
• Provide a daily summary of issues (Events, Deviations, Complaints, and TER's) logged in the previous 24 hours.
• Maintain the Clinical Quality investigation tracking spreadsheet(s). Ensure that it is updated in a timely manner and is kept current.
• Maintain the Clinical Quality Investigation folders and their associated documents
• Populate, maintain and update various spreadsheets utilized for trending of products, defects, lines, etc.
• Manage data entry in Excel Safe program for trending of issues.
• Responsible for tracking and ensuring timely completion of MasterControl eQMS Action Items and CAPA effectiveness activities.
• Maintains required Quality Metrics (Documents, Investigations, and CAPAs) on a routine basis including daily site updates, weekly site updates, monthly site metrics, monthly global metrics, and quarterly management reviews. Periodically facilitate site "Daily Direction Setting" (DDS) meetings.
• Work with affected functional areas to gather the necessary information for events, deviations, nonconformances and complaints to ensure effective investigations and corrective actions are performed and implemented.
• Perform and document investigations in response to events, deviations, nonconformances and complaints, utilizing root cause analysis techniques, when appropriate.
• Develop, write, revise and review clinical work practices and forms. Support the document change control process, when required.
• Perform and document the monthly temperature and humidity trending and reporting.
• Provide assistance (when needed) in the performance of Quality Control and Inspection activities to ensure adequate support for the warehouse and production teams.
• Provide subject matter expertise, support and training to other PCI staff concerning activities associated with your key areas of responsibility (KARs).
• Ensure that all assigned training is completed on time and in compliance with PCI training requirements and expectations.
• Provide support during regulatory, customer and internal audits and inspections, as needed. This includes assisting in pre- and post-auditing preparations and activities.
• This position may require overtime and/or weekend work.
• Knowledge of, and strict adherence to, all PCI, cGMP, and GCP policies, procedures, rules, etc., is required.
• Attendance to work is an essential function of this position
• Performs other duties as assigned by the Director of Clinical Quality Services or designee.

QUALIFICATIONS:

Required:

• Associates Degree in a related field and / or 1-3 years related experience and / or training.
• Basic 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.
• High Reasoning: Ability to solve practical problems and deal with a variety of concrete variables in situations where there is only limited standardization. Ability to interpret a variety of instructions that may be provided in various forms.
• Demonstrated working knowledge and experience with complaint handling, root cause analysis & techniques, CAPA, and conducting & documenting investigations in a regulated environment.
• Experience with facilitating, collaborating and working cooperatively in a team environment with personnel from other functional areas and / or customer representatives.

Preferred:

• Ability to demonstrate attention to detail.
• Ability to identify and resolve problems in a timely manner.
• Ability to work independently and/or as part of a team.
• Ability to display excellent time management skills.
• Ability to display a willingness to make decisions.
• Ability to display original thinking and creativity.
• Ability to adapt to changing work environments.
• Ability to set and achieve challenging goals.

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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.