Quality Engineering Analyst

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 for the product impact assessments related to Calibration OOS investigations and QC Lab Environmental Monitoring Investigations, writing or assisting with Key Critical Shared Service Investigations, and Quality Metrics (Weekly Site/NMR Supplier, Monthly Global Site, and Quarterly Site Management Review). This position assists with improving quality system processes via Process Mapping and Risk Management processes. Helps drive project success to provide PCI a competitive advantage in long-term quality customer management and maintaining GMP compliance and system improvement. In addition, this role involves performing Change Point Analyzer (CPA) activities, internal audits, upkeep of Excel Safe lot trending worksheets, and assisting as needed in POF, CPV projects, and Item Number Certification.

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.

• Investigate Shared Services quality events and trends (i.e. not related to customer or product).
• Assist with the investigation of Calibration OOS events and perform product impact assessments associated with such events.
• Review and approval of OOS investigations, Shared Service Investigations, and Investigations.
• Assist with the investigation of QC Laboratory Environmental Monitoring failures and perform product impact assessments associated with such events.
• Technical writing, support, and review around deviation investigations, etc.
• Work with internal customers to resolve issues associated with quality events.
• Develop and implement corrective and preventive actions.
• Write/Revise SOPs/WP's/Job Aids and submit change control and route in the E-Doc system.
• Initiation and technical evaluation of change controls including risk assessment/implementation of risk mitigation strategies.
• Generate and manage Quality-related Weekly, Monthly, and Quarterly metrics (generate data and prepare graphs and charts from various data sources.
• Create Quarterly PowerPoint presentations and post Monthly site reports.
• Update Monthly Global Site Reports and create Weekly Critical and Major Deviation reports for Commercial and Clinicals.
• Create detailed Bi-Monthly Quality Thursday Metrics (as needed) and provide weekly NMR Quality Supplier metrics.
• Create and provide Critical Control Points and Critical Process Parameter information for Customer/Product Critical Quality Attributes (APR CQA, CCP, and CPP) for use with APRs.
• Provide Equipment Calibration Review information for APRs
• Management and leadership of risk management activities and create and complete FMEA (Risk Assessments) and/or Process Maps for Commercial and Clinical Production processes/equipment and other non-production process functions for all Rockford sites.
• Analyze systems, processes, and procedures to identify potential failure modes that may result in quality defects. Meet with management and supervisors to discuss Preventative and Corrective actions for Medium and High-Risk defects identified through FMEA.
• Perform Change Point Analyzer (CPA) activities and maintain the schedule for Excel Safe spreadsheets.
• Excel safe administrator and upkeep of Excel safe lot trending spreadsheets.
• Responsible for the administration, implementation, and project management of assigned, special projects, including using standardized methodology.
• Lead and participate in internal audits.
• Participate in customer audits and regulatory audits as needed.
• Assist with Item Number Certification, Point of Failure (POF) data collation, and Continued Process Verification (CPV) activities as needed.
• Present quality-related metrics and key performance indicators for the team's performance.
• Assists with coordinating quality activities of the team to ensure that the goals and objectives of the team are accomplished.
• 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 Manager/Supervisor.

Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Required:

• Bachelor's Degree in a related field and/or 5-10 years of related experience and/or training.
• College Level Mathematical Skills
• Intermediate Computer Skills: Ability to perform more complex computer tasks and know 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.
• High Standard of Report Writing
• Statistical knowledge and applied experience

Preferred:

• Ability to set and achieve challenging goals.
• 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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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.