Qa Qc Manager - Hiring Asap

Job Description:

Manage and oversee all aspects of Quality Control, Quality Assurance, and Food Safety for the company specifically regarding cGMP Compliance under 21 CFR Part 111 and Part 117. Train & track all members of the company in procedures specific to their positions, and those position related to their jobs.

Specific Job Responsibilities:

• Administering the company quality program in accordance with the FDA, customer and company requirements
• Determine, establish and enforce through all operational departments, quality and safety requirements in accordance with company needs, based on current regulatory guidelines.
• Be formally HACCP trained and competent enough to implement and maintain HACCP based food safety and food defense plans
• Act as a liaison with external parties on matters relating to the quality system and support all operational departments.
• Assure that GMP Compliance is maintained throughout the company.
• Responsible for the training of all personnel in cGMPs and creating internal audits, as well as overseeing external audits including FDA, certification, retail and customer audits.
• Assure that all personnel are trained in all procedures that pertain to their specific job function and proper documentation is filed appropriately.
• Responsible for Review, Revision, Creation, and Maintenance of all company Standard Operating Procedures (SOPs) and controlled documents (forms, checklists, flow chart, hazard analyses, committees, etc.)
• Assure that all documentation is maintained, updated, reviewed and approved to reflect current processes.
• Manage & Maintain a system for customer complaints. Assure that all complaints are recorded properly and are closed out upon resolution with the customer.
• Create, Manage & Maintain specification sheets for all components, raw materials and finished products. Assure all components and raw materials meet specifications for use in processing of intermediate and final product by documented methods of sampling, testing, formulation, labeling, storage, distribution and approvals
• Assure that all process errors, product failures and any process deviations are investigated and that any corrective actions and/or preventative actions are carried out timely and documented.
• Report to the President any regulatory issues that need to be addressed and communicate with any Regulatory Agency as required.
• Help build our in-house micro and analytical lab.
• Manage the requirements and the renewal periods to withhold all aspects of the current NSF cGMP, Organic & Kosher, and any other certifications that the company currently holds as well as the regulatory process documentation for brand owners, retailers, etc.
• Review current Batch Records system and help in a team environment to improve record keeping as needed.
• Manage in-house microbiological laboratory including ordering of laboratory supplies, review of in-house results, training and performing in-house testing.
• Maintenance of stability program – internal or outsourced to 3rd party.
• Review and release of raw materials and finished products.
• Creation and review of Master Manufacturing Records
• Compliance review and release of product labels both in draft and print form.
• Schedule and maintain random lab testing to challenge supplier’s Certificates of Analysis (COAs) and customer’s Label Claims over and above the standard QC scheduled testing.
• Approve and manage the supplier qualification program.
• Implement Change Controls when required.
• Conduct material disposition and complete required documents for the same when required.

General Job Responsibilities:

• Present oneself in a professional manner towards all visitors, including truck drivers, customers, vendors, or employee guests.
• Show all fellow employees respect and professionalism at all times. Bring any concerns to a supervisor or member of management as soon as possible. Make every attempt to keep the work environment respectful, productive and satisfactory for all employees.
• As a member of Management, keep internal company information inside the Management fold until such time as announcements will be made to the rest of the company, &/or the public.
• As a member of the Company, keep customer information private at all times. GMP-N signs a ‘Non-Disclosure Agreement (NDA)’ with every customer and with that agrees to keep their information private & confidential outside of our work environment, including that they are a customer of GMP-N.
• Awareness of current status of production line activities related to quality and packaging of finished goods including labeling of containers, sealing jars properly, gross weight of units, gross weight of cartons, sealing cartons properly, appearance of finished units, appearance of finished cartons, labeling outside of cartons clearly and accurately with lot#, description of contents and accurate count, stacking cartons on skids appropriately, wrapping pallets securely while maintaining the quality of cartons appearance during shipping long distances and clearly marking the pallet to reflect contents and any special notations such as mixed lot#s, mixed items, etc. It is the responsibility of every member of Management to confirm that what is in the container, or carton, matches what is written on the label or box sticker. Any concerns should immediately be brought to the attention of the Production Manager, Quality Department, Warehouse Manager &/or Operations Manager (in that order).
• When Necessary, Train Production Technicians and New Hires (or Temporary Workers) on Company Policy and Production Actions and Techniques.
• Bring all matters that have the potential to affect the Company’s Integrity or Reputation of Quality IMMEDIATELY to Upper Management.
• Report all Equipment Malfunctions or Issues to Management quickly, and regularly, until matter is Addressed or Resolved.

Knowledge, Skills, and Abilities

• Working knowledge and understanding of current Good Manufacturing Practices (cGMP) for the Dietary Supplement Industry 21 CFR Part 111 and Part 117.
• Basic Analytical skills pertaining to manufacturing and laboratory activities
• Good verbal and written communication skills
• Personal computer literate including Internet Search, MS Word, MS Excel, MS Outlook.
• Ability to observe, monitor and write procedures before, during and after production takes place.
• Strong people management skills.