Sr. Compliance Associate I

PCI Pharma Services; San Diego (CA); On-site; USD 41,000 - 47,000; Full time

Benefits offered by this job

Paid time off

Health insurance coverage

401(k) plan

Flexible spending account

Job summary

PCI Pharma Services in San Diego is seeking a Sr. Compliance Associate I to lead customer audits and support the internal audit program within a GMP environment. You will collaborate with SMEs to address findings, help establish Quality Agreements, and support the vendor management program.

The role requires a Life Sciences degree and a minimum of 6 years in QA, with strong regulatory knowledge and experience in GMP drug product manufacturing. A comprehensive benefits package is provided.

Qualifications

• Bachelor's degree in Life Sciences or equivalent experience.
• Minimum 6 years of QA experience in a regulated industry.
• 2+ years of GMP manufacturing experience preferred.
• Strong regulatory knowledge for aseptic drug product manufacturing.
• Hands-on experience with QMS data management software.

Responsibilities

• Lead customer audits and coordinate with SMEs to address findings.
• Support vendor management, on-site or paper audits, and QA agreements.
• Support internal audit program and risk management activities.
• Contribute to continuous improvement of the QMS and SOPs.
• Generate quality system metrics for management reviews.
• Train team members on internal and external audits.
• Maintain consistent attendance and professional conduct.

Skills

Audit leadership

Regulatory knowledge

Communication skills

Training teammates

Education

Bachelor's Degree in Life Sciences

Tools

ACE

TrackWise

MasterControl

ETQ

Job description

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:

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.

Shift:1st

ESSENTIAL JOB FUNCTIONS-OTHER DUTIES MAY BE ASSIGNED:

• Leads customer 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 Quality Agreements
• Supports the execution of internal audit program
• 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 quality systems
• 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.
• Embodies PCI Pharma Serivices cultural values and aligns daily actions with department goals and company culture.

EDUCATION AND EXPERIENCE:

• 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 $29.65 - $33.36 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.