Quality Control Manager

POSITION: Quality Control Manager

REQUIREMENTS:

• Combination of advanced degree (such as Bachelors or Masters in science) and 3+ years of experience in high volume manufacturing preferred
• Previous experience within a cGMP compliant facility and Quality Assurance/Quality Control preferred
• Ability to perform physical sampling/testing and instrumental chemical analysis in the chemical laboratory (e.g., chromatography, infra-red spectroscopy, titrations, etc.)
• Excellent analytical and problem-solving skills
• Excellent time management and organizational skills
• Ability to work effectively in a fast-paced, rapidly changing environment
• Excellent people skills, with demonstrated ability to communicate effectively across functional groups
• Proficiency with Microsoft (MS) Office

JOB DESCRIPTION:

The Quality Control Manager will perform their role as follows:

Reports to Quality and Regulatory Affairs Manager

• Assist with the developing, implementing, maintaining and adherence of the Quality System
• Manage departmental activities in accordance with available budget, resources and personnel
• Interviews, hires and trains department staff
• Manage the Quality Control internal laboratory activities and analytical team which includes the analysis of raw materials, batches, and finished products.
• Assist with all Regulatory and Customer inspections
• Assist with reports and other documentation as required by Regulatory agencies and Customers, including post-marketing surveillance activities such as Product Recalls
• Assist with Vendor Qualification program by reviewing and testing raw materials.
• Review and approve internal laboratory testing and external contract testing laboratory reports for materials and finished products. Manage the selection and qualification of external laboratories for required testing,
• Review and approve master batch records prior to quality release.
• Review and approve Certificates of Analysis
• Prepare, review and approve IQ/OQ/PQ Protocols/Reports for production and laboratory equipment / instruments
• Prepare, review and approve new and revised Standard Operating Procedures (SOPs) and Forms
• Prepare, review and approve investigations and corrective/preventative actions (CAPA)
• Manage the facilitys Purified Water System, working with a third-party for maintenance and water testing.
• Oversees and maintains the Pest Control program for site.
• Manage the facilitys Environmental Monitoring Program
• Perform additional job-related duties, as required
• Delegate responsibilities to assigned designees, as necessary