Quality Assurance & Quality Control (QA & QC) Manager –

Quality Assurance & Quality Control (QA & QC) Manager |

Quality Assurance & Quality Control (QA & QC) Manager

We are looking for “QA & QC Manager” with the following job description and requirements:

Duties & Responsibilities

• Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and clients’ standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
• Develop and maintain a Quality Management System in accordance with domestic and international medical device regulatory requirements (FDA, ISO13485, MDD, Health Canada, etc.)
• Manage Quality Control related activities regarding all in-process checks, deviations, RM release, and finished product release. Ensure that products conform to specifications and regulatory requirements.
• Approve or reject all formulations, procedures, specifications, test methods, raw materials, packaging materials, and finished products, including products manufactured at foreign sites, based on conformance / non-conformance to respective specifications that affect the purity, quality, and composition of each product.
• Oversee complaint handling, corrective and preventive actions, internal audit program, supplier quality assurance, product inspection and release, equipment calibration, and control of nonconforming material.
• Maintain and improve product quality by completing product and company system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop a new product, and manufacturing and training methods.
• Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
• Approve Raw Material Specifications before purchase. Develop Finished Product Specifications for existing & New Products.
• Prepare a Certificate of Analysis for all clients, prepare Stability reports and Nutritional Facts for products.
• Maintain Master formulations, Change Control, and history records. Develop & make a master formula for all new registrations. Identify and analyze issues related to in-process manufacturing and resolve them.
• Review & maintain Work Orders and all related documents. Complaint handling: record all details about the complaint and prepare a complete investigation report, corresponding to the client till it’s resolved.
• Communicating with clients and Laboratory for technical matters. Ensure that the contract laboratories are capable of performing all of the tasks and responsibilities assigned to them.
• Review and verify test protocols, COA’s received from the third-party laboratory. Investigate OOS results received from the laboratory and find solutions.

Minimum Requirements

• Minimum BSc. in Chemistry, Biology, Pharmacology, or Food Science obtained by recognized University.
• Around 5 years of experience in a Natural Health Supplements/pharmaceuticals manufacturing environment.
• Basic knowledge in CFIA FSEP Manual and HACCP System preferred.
• In-depth understanding of quality systems such as ISO 9000, GMP, FSSC 22000, HACCP training certification.
• Knowledge in Natural Health product formulation is an asset.
• Flexible and able to operate in a fast-paced environment.
• Excellent numerical skills and understanding of data analysis/statistical methods.
• Good knowledge of MS Office and databases.
• Great attention to detail and a result-driven approach.
• Excellent organizational and leadership abilities.

Salary: Based on experience.
Job Location: Maple Ridge, BC
Job type: Full time permanent
Benefits: After the probationary period