A solution provider that will lead the creation, improvement, maintenance, and overall effectiveness of the Quality Management System (QMS). Drive compliance to federal Quality regulations, provide leadership to the Quality team and foster a culture of Quality across the organization. Tracks and reviews all Quality systems to promote continuous improvement and corrective and preventative actions as needed.
location: Santa Clarita, California
job type: Permanent
salary: $75,000 - 80,000 per year
work hours: 9 to 5
- Leads development, implementation, and oversight of the Quality Management System to ensure compliance with Federal regulations for OTC and cosmetic products
- Leads and supports a corporate culture of Quality and compliance by mentoring and developing staff, through regularly communicating vision and priorities to both the Quality team and senior leadership
- Develops an in-depth understanding of existing processes and the needs of the business to identify opportunities for process improvement and the tools necessary to both implement and measure plans of correction through direct engagement and analysis
- Establish and Maintain the Quality Management System to meet the relevant Regulatory requirement and ensure operational excellence is maintained across functions. Direct Quality Assurance activities, including but not limited to:
- CAPA, Complaints,
- Document Control - Change Control
- Non-Conforming Product
- Internal - External Quality Audits
- Analysis of Data
- Management Responsibility and Quality Records
- Hands on management role that actively contributes to the activities above while developing a team, working to ensure adherence to company quality standards and regulatory requirements
- Established or re-engineers Quality processes to continually improve operational efficiencies and minimizes technical difficulties. Quickly identifies solutions to problems and assures corrections are expeditiously implemented.
- Establish Quality metrics and goals. Work with all groups to assure the achievement of goals.
- Bachelor's degree (BS) in a science related field preferred
- Three (3) to five (5) years Quality experience in a FDA regulated manufacturing facility
- Management experience or experience functioning as a managing lead
- Strong knowledge of functional Quality Systems
- Proven leadership and project management skills.
- Strong cross-departmental communication skills, someone who enjoys working cross-functionally, helping to identify important department interfaces.
- Demonstrates excellent interpersonal skills with personnel at all levels and exhibits a high degree of initiative, enthusiasm, commitment, and motivation.
- Strong understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices(GDP)
- Strong demonstrated verbal/written communications, analytical, and problem solving skills. Must be detailed and results oriented.
- Extensive understanding of MS Office applications
- Strong writing and documentation skills
skills: Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.