The Quality Manager will be responsible for managing the site's quality systems and QA department.
Responsibilities
Manage the site quality systems program: deviations, CAPA, change controls, complaints, internal audits, document retention, etc.
Lead activities to reduce quality complaints
Establish and maintain effective, professional relationships with our internal and external customers to support production ensuring only quality product is released to the market
Implement a full CTQ (Critical To Quality) system with metrics
Establish and lead Customer Quality review process
Maintain ISO standards and execute action items to ensure compliance
Manage and mentor personnel in the Quality Control and Quality Assurance departments, including evaluating competencies and performing periodic performance assessments.
Evaluate staff resource needs and prioritize as appropriate.
Perform recruiting and training tasks for new personnel.
Maintain Quality Control and Microbiological testing activity records and retention samples.
Implement Supplier CAPA Program
Approve specifications for new or revised products, components, and raw materials.
Resolve quality issues or events discovered during GMP checks, QC testing, and audits.
Evaluate and approve new testing procedures as supplied by outside customers and R&D.
Represent the Quality Group in management team meetings.
Manage documentation for GMP activities.
Formulate, implement, interpret, and champion policies and operating practices.
Lead Customer and agency audits for the Site
Other duties as assigned.
Minimum Education & Experience
Bachelor's degree in chemistry, biochemistry, or related field.
Minimum 8 years' experience in a QA/QC manufacturing environment with at least 3 of those years in a leadership role.
Management experience overseeing a QA or QC function in manufacturing
Knowledge, Skills & Abilities
Detailed understanding of 21 CFR and ISO.
Practical knowledge using Design of Experiment (DOE) and data analysis tools.
Exceptional organizational skills in handling multiple priorities and meeting required business objectives and milestones.
Ability to read, write, and speak English competently.
Ability to speak Spanish is preferred
Preferred Knowledge, Certifications, Skills & Abilities
Comprehensive experience with analytical laboratory tools and software systems supportive of the needs of the function.
Thorough understanding of good manufacturing/laboratory practices (GMP/GLP) and regulatory compliance/documentation requirements.
Proactive professional with well-developed analytical & problem-solving skills, oral/written communication skills, and project management skills.
Travel & Working Conditions
Primarily office or lab environment - climate-controlled.
Periodic visits to:
o Warehouse environment - some temperature extremes, dust, and noise.
o Manufacturing environment - some temperature extremes, dust, noise, and wet.
o Potential exposure to hazardous chemicals.
o Requires use of PPE such as safety glasses, hairnets, or gloves
Annual Travel expectations up to 10%