Sr. Quality Compliance Associate I - Audits

Sr. Compliance Associate I

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.

The Sr. Compliance Associate I will utilize their skills to hosts customer and regulatory audits, assist in the execution of internal audits, and provide support to the vendor management program. This role is a great fit for a candidate who is both personable and highly knowledgeable of the Quality Management System.

Essential Duties and Responsibilities:

• Leads customer and internal audits, collaborates with Subject Matter Experts to address audit findings, and tracks the customer audit program for continuous improvement
• Supports vendor management program, occasionally conducts on-site and paper audits, and establishes Supplier Quality Agreements
• Supports risk management program
• Supports the continuous improvement of the Quality Management System
• Reviews and approves quality management system standard operating procedures (SOPs)
• Reviews and approves deviation reports and CAPAs related to regulatory inspection/audit commitments
• Generates quality system metrics for management review meetings
• Trains team members on conducting internal and external audits
• Regular and reliable attendance on a full time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures.

Qualifications:

Required:

• Bachelor's Degree in a Life Sciences discipline or equivalent relevant experience required.
• Minimum of 6 years of relevant QA experience in a regulated industry.
• At least two (2) years relevant experience of manufacturing in a GMP environment or Drug Product Manufacturing Preferred.
• Advanced-level understanding of regulatory requirements related to aseptic drug product manufacturing and testing.
• Knowledge and hands on experience with QMS data management software such as ACE, Track Wise, Master Control, ETQ, etc.
• Highly effective in collaborating with internal and external customers, leading improvement projects, and training team members on internal and external auditing.
• Detail-oriented with strong organizational skills.

The hiring rate for this position is $40.92 -$46.04 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), a flexible spending account, and a 401(k) plan.

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.