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.
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:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The basic duties and responsibilities include the following, but other duties may be assigned.
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:
The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
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.
Physical Demands:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties the employee is:
constantly required to sit, and to reach to use computers and other office equipment
constantly stand for extended periods of time, up to four (4) hours/time.
frequently required to lift up to 40 pounds
constantly required to view objects at close and distant ranges with hand and eye coordination
frequently required to communicate with others
Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.
*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.
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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.
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-chanceTop Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
