What are the responsibilities and job description for the Sr. Quality Compliance Associate I - Audits position at PCI Pharma Services?
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 Title
Sr. Compliance Associate I
Overview
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
Required:
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.
IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:
For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair-chance
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 Title
Sr. Compliance Associate I
Overview
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.
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.
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.
IF YOU ARE A RESIDENT OF CALIFORNIA OR APPLYING FOR A JOB IN CALIFORNIA PLEASE READ:
For Los Angeles applicants, we abide by the Fair Chance Initiative for Hiring. Learn more about the policy here: https://bca.lacity.gov/fair-chance
Salary : $41 - $46