Quality Compliance 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.

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.

Job Details:
The Quality Compliance Specialist supports the site compliance and regulatory strategies necessary to support customer's products as well as leading both regulatory inspections and customer audits. They are responsible for supporting the implementation of company policies and objectives involving matters of government and regulations, with respect to the FDA, DEA, and other ex-US regulatory agencies as applicable. The role will also provide support for client business reviews, investigations, complaints, CAPAs, inspections, quality metrics, and continuous improvement initiatives as required by the company supervisory responsibilities for the role.

• Ensure compliance with domestic and international drug, device and biologic regulations with a strong focus on the FDA, DEA, and other ex-US regulatory agencies as required.
• Manage the Customer and Regulatory auditing program by completing required pre-audit documentation, lead audit hosting, developing appropriate corrective actions documented through the audit report responses, and ensuring proper implementation.
• Maintain a systematic approach to sharing audit (customer and regulators) observations and associated corrections with all site team members and also the corporate quality team.
• Review and maintain appropriate Customer Quality Agreements.
• Review and maintain appropriate Site Master Files.
• Implement and support programs that establish and maintain a culture that fosters compliance with company rules and all applicable federal, state, and local regulations.
• Utilize Continuous Improvement tools as required.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules.
• Support wider aspects of the Quality Management System to maintain compliance and drive improvements
• This position may require extra hours 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.

Required:

• Bachelor's Degree in a related field and/or 1-5 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.

The base salary range for this position is $68,400.00 to $75,000.00 plus annual performance bonus eligibility. Final offer amounts are determined by multiple factors including and not limited to specific and relevant experience, credentials, geography and subject matter expertise.

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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.