Job Description

Job Description:

The Quality Control Manager will provide strategic leadership for a Quality Control team and work closely with Regulatory, Purchasing, Logistics, Customer Service and the Production Planning team. The individual in this role must have expertise in Quality Control operations, quality systems and managerial experience. Our Quality Control Managers primary goal is to validate incoming raw materials through the production process, and into the finished goods phases of operations. To do so, the Quality Team oversees current production processes utilizing an array of raw test methods to ascertain compliance. The Quality Control Manager reports to the Senior Quality Manger.

Job Responsibilities:

• Responsible for designing, writing, and maintaining Quality Management System (QMS) including SOPs.
• Perform Internal and External CAPAs.
• Resolve non-conformity issues.
• Oversee and validate standardized testing methods for incoming materials and finished product to confirm accuracy.
• Schedule daily, weekly, yearly work assignments for quality team.
• Scheduling annual preventative maintenance for equipment.
• Assist in on-site auditing projects.
• Responsible for handling department email/phone interactions.
• o Document requests.
• o Customer complaints.
• o Status updates.
• Assist with scheduling projects as directed by the Vice President Global Operations.
• Assist with projects directed by the Senior Quality Manager.
• Oversee proper disposal of expired materials/products.
• Implementation of safe work practices.

Requirements:

Education and Experience:

• Bachelors degree in chemistry, microbiology, engineering or related field
• Minimum 5 years of leadership experience in Quality Control Onsite presence required.
• Extensive knowledge and experience with compliance, compendial and regulatory requirements.
• Experience with regulatory inspections and audit readiness.
• Demonstrated problem-solving and decision-making capability.
• Demonstrated technical writing skills.
• Proven cross-functional leadership and project management experience.
• Excellent verbal communication and presentation skills.
• Production skills: Knowledge of Good manufacturing processes (GMPs).
• Ability to work well under pressure.
• Deadline oriented.
• IT skills - Proficiency in using common PC applications.
• Excellent ability to work with others.
• Cognitive (Reasoning):
• o Apply principles of rational systems to solve practical problems and deal with a variety of
• concrete variables in situations where only limited standardization exists.
• o Interpret a variety of instructions furnished in written, oral, visual, or schedule form.
• Communication:
• o Vocalize and explain detailed data and problem-solve, both in-person and by telephone. Must have good communication skills (both verbal and written)
• o Compose routine correspondence on own initiative.
• o Make comprehensive notes in English.
• o May involve a large volume of such composition.
• o Must have ability to work well under pressure.
• o Send follow-up emails and provide requested documentation to other departments.
• o Maintain clear and timely communication with other departments, providing status updates as needed.
• o Assist with work scheduling as directed by the Quality Manager.
• o Collaborate effectively with team members and provide support as needed
• Physical Capabilities
• o Strength (lifting, dexterity, repetitive motion):
• Must be able to lift 40-lbs onto waist high shelves.
• Must be able to lift and carry a min of 25lbs.

Movement: Employee will frequently use fingers, walk and distinguish basic colors. Employee will continuously use both hands, sit for extended periods of time, and use rapid or well developed coordination simultaneously.

o Hearing: Must be able to hear and understand work direction in a loud, distracting environment

o Vision: Must be able to judge distance, identify details, and view computer screen regularly

• Compensation:
• Competitive market-based salary; commensurate with experience

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