Pyramid Pharma Services · 2 weeks ago
Sr. Quality Assurance Specialist/Supplier Audits
COSTA MESA, CA, US
Full-time
Onsite
Senior Level, Lead/Staff
$80K/yr - $90K/yr
8+ years expPyramid Pharma Services is seeking a Sr. Quality Assurance Specialist/Supplier Audits to oversee supplier audits and support quality compliance processes. This role involves planning and conducting audits, managing supplier qualifications, and collaborating with various departments to resolve compliance issues.
Manufacturing
Responsibilities
Plan, schedule, and conduct internal company audits and supplier audits to assess compliance with applicable regulatory requirements
Generate and review supplier quality agreements
Coordinate with third-party audit providers for international supplier assessments, as needed
Oversee aspects of the vendor qualification program, including maintaining approved supplier documentation and records in the quality management system
Manage corrective action request programs related to supplier and audit findings
Maintain and organize documentation related to audits, vendors, and compliance activities in the quality system
Evaluate audit findings, determine risk levels, and monitor the implementation of corrective and preventive actions
Participate in audit-related reporting and present key audit metrics to quality leadership
Collaborate with various departments to support quality and compliance functions across operations
Assist in preparation for regulatory inspections and internal readiness initiatives
Assist in the implementation of corrective and preventive actions (CAPAs) across departments when needed
Perform additional duties in support of overall quality and compliance goals
Excellent knowledge of quality control standards and testing methodologies
Review laboratory data to ensure accuracy, completeness and compliance with internal procedures and regulatory standards
Assist with the investigation and closure of non-conformances, as needed, ensuring appropriate corrective and preventive actions (CAPA) and change controls are initiated and deviations are closed
Author, review and approve standard operating procedures (SOPs) in alignment with quality standards and regulatory guidelines
Qualification
Required
Proven track record of conducting supplier audits and driving quality improvement initiatives
Exceptional communication and interpersonal skills to effectively manage supplier relationships
Strong organizational skills and attention to detail in managing multiple projects
A proactive mindset with a commitment to continuous improvement
Strong interpersonal skills and demonstrated ability to work collaboratively in a team-oriented environment
Self-motivated with the ability to manage multiple tasks and meet deadlines
Adaptable to changing priorities and able to thrive in a fast-paced dynamic environment, while maintaining quality standards
8+ years of relevant work experience in quality management, with a focus on supplier quality in a pharmaceutical manufacturing environment
Minimum 5 years of Supplier Quality experience required
5+ years of Leadership required
5+ years of Internal Audits experience
Proficiency in Microsoft Office Suite: Strong knowledge of Word, Excel, PowerPoint, Access, and Outlook
Bachelor's degree in chemistry, biochemistry or related field
Preferred
Quality Auditor Certification (e.g., ASQ, CQE) preferred
Company
Pyramid Pharma Services
Founded in 1988 as Pyramid Labs, Pyramid Pharma Services is a Drug Product CDMO specializing in injectable drug product development and manufacturing.
51-200 employees
H1B Sponsorship
Pyramid Pharma Services has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2020 (1)
Funding
Current Stage
Growth StageTotal Funding
unknownKey Investors
Audax Private Equity
2023-04-18Private Equity
Leadership Team
Dirk T. Lange
Chief Executive Officer
Recent News
2025-02-14
Company data provided by crunchbase