QA Supervisor Lake Forest, California
Job Ref: 35823
POSITION SUMMARY STATEMENT:
The Supervisor, Quality Assurance is responsible for the supervision and coordination of all Quality Assurance (QA) inspection activities and for providing daily support company Manufacturing in Quality related issues. The Supervisor, Quality Assurance directly supervises technical employees across all 3 shifts to maximize productivity of assigned shifts and areas at the highest quality and safety standards. This role will partner with HIM production management to identify and resolve quality issues expediently with adherence to applicable practices, regulations and requirements.
•Ensure adherence with current Good Manufacturing Practices (GMPs), SOPs, state and local regulations, in addition to customer specific requirements.
•Ensure QA review and approval of HIM processes, Standard Operating Procedures (SOPs), specifications, analytical tests and examinations, and deviations or modifications to them.
•Supervise, train, motivate and develop the Quality Assurance Technicians across 3 shifts
•Participate in and/or lead implementation of quality strategies, improvement of quality standards, goals and objectives.
•Conduct and/or assist in investigations concerning operational problems, production errors, and/or problems involving customer complaints, and ensures required material reviews and disposition decisions are properly conducted.
•Perform corrective and preventative actions regarding internal and third party audit deficiencies and performs quality line checks.
•Supervise the approval or rejection of components, labeling, in-process material, and finished products.
•Ensure that line inspection and in-process checks are properly conducted.
•Ensure representative samples of all in-process materials, labeling, packaging, and finished products are collected, tested, and held.
•Conduct periodic plant audits for strict adherence to cGMPs and SOPs.
•Oversee the maintenance of the Retain Sample Program and Environmental Monitoring Programs
•Perform investigations of customer complaints and identify corrective actions; assist in implementing corrective or preventative actions (CAPA) to ensure product quality.
•Help develop and implement Process Monitoring Systems by identifying critical process steps which could culminate in possible sources of manufacturing defects and devising methods to reduce process variation in order to reduce/eliminate the cause of defects.
•Perform trend analysis and report analysis to management as appropriate.
•Gather data on performance metrics to facilitate the review of program/product effectiveness, efficacy, and actions for adherence to quality.
•Under direction of the QA Manager, may perform or oversee the completion of certain job functions required by a certified Preventive Control Qualified Individual (PQCI).
•Provide customer service to all employees needing assistance with GMP, GCP and GLP controlled documentation
•Oversee the update and maintenance of manual and electronic tracking lists in the Quality Assurance databases.
•Ability to generate reports or matrices for QA department.
•Interact effectively with co-workers, management and vendors in order to effectively resolve problems.
•Perform all responsibilities in accordance with company guidelines and Standard Operating Procedures (SOPs) and appropriate industry and regulatory standards, guidelines, rules, and regulations.
•Ensures ongoing and timely support of project-related activities and tasks.
•Performs other related duties as assigned by management.
The Supervisor, Quality Assurance will oversee a team of 12-20 across 3 shifts
Ability to effectively manage and develop employees of various skill & experience levels
Superior technical writing and problem solving skills
Must be capable of organizing data from multiple sources, extracting key information and documenting investigation detail
Ability to communicate effectively both verbally and in written English.
Strong investigative skills
Knowledge of Good Manufacturing Practices, Food and Drug Administration (FDA) regulations (FDA 21 CFR – Part 111, Part 112, Part 114 and Part 117) and documentation procedures
Demonstrated ability to be self-motivated as well as to work collaboratively in a team-based environment •
High degree of attention to detail
Must demonstrate initiative and a willingness to learn
Ability to organize workload, prioritize responsibilities, meet deadlines and multi-task on several projects individually as well as in a team environment
Proficient use of MS Office, including Word and Excel
Strong organizational skills, detail-oriented
Coordination between departments in a cooperative and professional manner
Previous knowledge and understanding of Quality compliance
•Working knowledge of GMP and QA/QC in the food, nutraceutical or pharmaceutical industry
•2+ years Supervisory experience in a quality/regulatory department
•5+ years Quality related experience in a food or dietary supplement industry
•BA/BS degree in a scientific field required
•Strong verbal and written communication skills.
•Experience with Oracle
•Previous experience working in a food or dietary supplement manufacturing plant Quality Assurance setting
•ASQ, Six Sigma, or applicable certifications
•Experience with Oracle, Agile, MasterControl
•Proficiency in Microsoft Office products – MS Windows, Word, and Excel
•ASQ Quality related certifications (i.e. CQI, CQA, CHA, CQE, etc.)
•Experience using data analysis computer tools and statistical analysis
•Three years Quality Assurance Supervisory experience in a regulated GMP environment