Quality Assurance Manager

PERFORMANCE EXPECTATIONS

• Support the implementation and maintenance of the quality management system
• Oversee companywide continuous improvement as related to the QMS and all applicable
• regulations (GMP, ISO)
• Ensures compliance with all applicable FDA, OTC, ISO, EPA requirements.
• Lead and support all audit preparation activities and participate in regulatory authority audits.
• Lead and participate in companywide compliance efforts, ensure compliance, and support all
• facets of the internal audit system.
• Prepare and evaluate trends in the quality system to monitor effectiveness. Develop metrics to
• support quality goals and objectives.
• Manage SOPs, Work Instructions, Forms and other controlled documentation.
• Manage and participate in formal problem-solving processes, conduct root cause analysis and
• corrective action investigations.
• Reviews the inspection and testing of materials, parts, and products to ensure adherence to
• established quality standards.
• Oversee SOP development and processes to support all company activities and actions as well
• as training and training support.
• Foster the creation and application of improved quality methods, systems, and solutions to
• increase product quality, production efficiency and customer satisfaction.
• Manage quality compliance programs to ensure issue resolution and success
• Proposes corrective actions to improve compliance with quality specifications
• Recommends new or improved quality control methods, procedures, and/or standards
• Manages Quality Assurance staff in their day-to-day work performance.
• Ensures that project/department milestones are met by analyzing data on relevant
• performance indicators.
• Assist in audit preparations as needed
• Reviews out of specification investigation reports documenting problems observed in
• meeting quality standards or SOP’s
• Manages the storage and retrieval of work order history records and finished good certificates
• of analysis.
• Possess strong interpersonal skills with the aptitude to be a team player and leader: setting a
• professional tone and establishing a cooperative partnership in all departments throughout
• the company.

AUTHORITY
This position reports to the head of the Quality Management System and closely collaborates with
Manufacturing, Purchasing, Marketing, Administration and the Research and Development teams.
SUPERVISORY RESPONSIBILITY

• Quality Assurance
• CLASSIFICATION
• This is a full-time exempt role
• EDUCATION
• Bachelor’s Degree

WORK EXPERIENCE

• 5+ years employed in Quality, Regulatory, or related field in a cGMP Facility
• 2+ years in supervisory/management preferred
• Bilingual (Spanish) a plus

Job Type: Full-time

Salary: $90,000.00 - $140,000.00 per year

Benefits:

• Dental insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Experience:

• ISO 9001: 1 year (Preferred)

Ability to Commute:

• Watsonville, CA 95076 (Preferred)

Ability to Relocate:

• Watsonville, CA 95076: Relocate before starting work (Preferred)

Work Location: In person