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 facility’s Purified Water System, working with a third-party for maintenance and water testing.

Oversees and maintains the Pest Control program for site.

Manage the facility’s Environmental Monitoring Program

Perform additional job-related duties, as required

Delegate responsibilities to assigned designees, as necessary