Director of Quality - ChemRite

• Minimal BS degree in Chemistry, Biology, Quality Engineering, or other health related sciences.
• 3-5 years of experience managing a quality assurance department in a manufacturing environment.
• Deep knowledge of cGMP, FDA regulations, and CFR 21 compliance.
• Experience with successful implementation and oversight of compliance programs.
• Track record of leading quality assurance teams and managing audits, inspections, and regulatory submissions.
• Is an analytical and decisive decision maker.
• Has the ability to generate respect and trust from staff and external contacts.

• Lean Manufacturing, Six Sigma certifications, Certified Quality Auditor (ASQ CQA), or Certified Quality Engineer (ASQ CQE)
• Has bilingual English and Spanish skills.

• Manages daily activities of the Quality Assurance, Quality Control, Document Control, and Compliance departments.
• Proactively communicates with all department supervisors to achieve quality and compliance standards.
• Creates and monitors the monthly quality metrics and reports to management the monthly performance scores.
• Completes performance reviews for the quality unit on an annual basis.
• Reports to management on quality issues and trends (i.e., deviations, QA reporting, customer complaints, etc.)
• Carries out supervisory responsibilities in accordance with the organization''s policies and applicable laws.
• Responsible for interviewing, hiring, and training new employees.
• Ability to foster a culture of accountability.

• Oversees compliance with all regulatory bodies governing quality, environmental, health, and safety. Includes but is not limited to the FDA, EPA, OSHA, DNR, State, and Federal regulations.

• Prepares and facilitates customer and regulatory audits and or inspections.
• Reviews and approves changes to quality documents as necessary (i.e. QARMs, QAFGs, QAPMs, manufacturing records, project folders, QSM SOPs, etc.)
• Responsible for monitoring validation program. This includes cleaning validations, process validations, method validations, and equipment validations.
• Proposes, updates and enforces Quality Assurance policies and procedures (SOPS).
• Maintains oversight of the Vendor Qualification process and maintains the Approved Supplier List.
• Audits Quality System and vendors following audit guidelines.
• Ensure change control process is being followed.
• Investigates and writes all types of deviations, non-conforming products, and customer complaint reports.
• Interacts directly with customers regarding quality related issues.
• Investigates, develops, and recommends changes to processes and procedures to drive continuous quality improvement.
• Completes annual product review.
• Coordinates and facilitates third party audits when necessary.

• Works and collaborates with the sales and production team to review new business opportunities, develop new manufacturing processes, and onboard new customers.
• Ensures quality documentation is correct and in place for new business onboarding and is accomplished following efficient established procedures.

• Communicates respectfully with people at all levels both internally and externally.
• Gathers and gives relevant information to others in a timely manner (co-workers, customers, vendors).
• Actively participates in group discussions and brings ideas to management's attention.

• Acts consistently with company values and norms; effectively uses organizational guidelines and procedures to solve problems.
• Actively supports and implements company decisions. Places shared goals before narrower interests.
• Demonstrates good judgment in decision making and pursues win-win outcomes.

• Sets clear expectations and gains agreement on desired actions.
• Holds employees accountable for tasks and assignments; quickly reinforces or redirects performance when appropriate.
• Completes annual review with each direct report; clearly addresses action items to enhance performance.
• Regularly documents direct report's performance throughout the year, particularly when disciplinary action is required

Lewis & Clark Capital