Quality Assurance (QA) Manager - ChemRite

Job Description

Job Description

ChemRite CoPac is looking for a Quality Assurance (QA) Manager to be responsible for the day-to-day management and execution of the Quality Management System (QMS) for an FDA-regulated OTC drug and cosmetic liquid blend and fill manufacturing facility. This role ensures compliance with 21 CFR Parts 210 and 211 (OTC drugs), applicable cosmetic regulations (21 CFR 700 series, MoCRA as applicable), internal procedures, and customer quality requirements. ChemRite CoPac partners with customers to manufacture high-quality liquid products across a variety of package types while maintaining strict adherence to FDA, GMP, and customer-specific quality requirements.

The QA Manager serves as the primary Quality interface to Manufacturing, ensuring GMP compliance on the production floor, timely review and release of batch documentation, effective investigation of deviations, and proper implementation of cleaning validations, deviations, CAPAs and change controls. They are responsible for staffing, organization, and operation of the entire QA department. The role requires strong technical judgment, regulatory knowledge, and the ability to enforce Quality standards while supporting business objectives.

Listed below are the basic qualifications, required skills and competencies.

Basic Qualifications - Required:

• Holds a bachelor’s degree in chemistry, Biology, Engineering, or a related scientific field
• Minimum of 2+ years managing people
• Minimum 3-5 years’ experience in Quality Assurance in a GMP manufacturing environment (OTC, Pharma, Cosmetic, Personal Care).
• Proven experience in setting up and maintaining robust quality systems and a thorough knowledge of cGMP standards.
• Hands-on experience with batch record review, deviations, CAPAs, and change control
• Prior experience supporting FDA inspections and customer audits
• Attention to details and accuracy
• Excellent writing, communication, and Microsoft Office skills.
• Able to identify problems quickly and appropriate solutions in a fast-paced production environment.
• Demonstrates a strong sense of urgency and detail orientation.

Basic Qualifications - Preferred:

• Previous quality assurance management experience.
• Have excellent communication and computer skills.
• Hold certifications related to quality assurance.
• Has a strong track record in management skills.
• Has bilingual English and Spanish skills.
• Has good stress tolerance skills.

Key Responsibilities:

• The QA Manager supports the Director of Quality by executing and maintaining the Quality Management System on a day-to-day basis, escalating significant quality and compliance risks, and ensuring timely and effective implementation of quality decisions and initiatives.
• Manages daily activities of the Quality Assurance and Document Control Departments.
• Prepares and facilitates customer audits and governmental agency inspections.
• Proactively communicates with all department supervisors to achieve quality and compliance standards.
• Proposes, updates and enforces Quality Assurance policies and procedures (SOPS)
• Performs scheduled audits of the Quality System.
• Reviews and approves changes to Quality Assurance documents as necessary.
• Manages Document Control Specialists and oversees Master packaging records for new projects and document change controls.
• Investigates and writes deviation reports and customer complaint reports (CCR)
• Interacts directly with customers regarding quality related issues.
• Creates and monitors the monthly Quality Score Card.
• Reports to management on quality issues and trends (i.e. deviations, QA reporting, customer complaints, etc.)
• Oversees compliance with governmental agencies such as FDA and EPA, including inspections, record-keeping and annual reports completion.
• Completes annual drug reviews.
• Prepares and facilitates customer audits and governmental agency inspections.
• Responsible for monitoring validation program, this includes cleaning validations, process validations and method validations.

Required Competencies:

Communication/Interpersonal Skills: interacting respectfully and professionally.

• 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.

Organizational Commitment: aligning behavior with Company needs and priorities

• 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.

Managing People: managing others fairly and consistently

• 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.

Compliance: achieving quality results and customer satisfaction

• Promotes two-way communication and cooperation between internal departments to achieve efficiency, quality and profitability standards.
• Monitors and documents internal processes and procedures to ensure consistent, quality results.
• Facilitates customer and FDA audits.
• Ensures compliance with regulatory requirements associated with new and ongoing projects.
• Creates and monitors validation procedures to ensure full documentation and compliance