Quality Assurance Manager

P*osition Summary*

Management oversight of quality assurance and control to ensure products meet regulatory compliance, company policies, industry best practices, and customer standards. Supervise staff and oversee product manufacturing procedures to ensure that products meet quality standards and final specifications. Process and qualify all inbound materials and outbound finished products.

Primary Responsibilities

· Responsible for administration of: Procedures, Release of Product (QC Holds), Qualifying QC Specialists to act as QC Manager when QC manager is not on-site, Quality Department Head, and QA/ QC Operations.

· Asses potential production risks and report written suggestions to Operations manager.

· Oversee company quality policy and procedures. Assessing risk within the quality program.

· Technical support to ensure product quality and to identify/correct conditions that affect public, individual and plant safety.

· Daily stand up meetings with the production manager.

· Verify vendor qualifications and product specs.

· Setting requirements for raw materials from suppliers and monitoring their compliance.

· Inspecting the final output and comparing it to the product specs and approving or rejecting the final manufactured product.

· Take product samples for retention in accordance to the GMP program.

· Oversee third-party testing and use in-house laboratory HPLC machine for sample testing.

· Ensure GMP records are maintained in a complete and orderly manner including data recording, calculations, and proper labeling.

· Train new employees on SOP’s that pertain to their role under the cGMP program. When new or updated SOP’s are created, schedule training with the appropriate parties and document training took place.

· Document review.

· Recall Coordinator.

· Communicate with production manager and warehouse manager any QC issues that have affected order shipments.

· Report adverse issues to Operation Manager and follow through with corrections.

Other Duties
Please note this job description is not designated to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Requirements

· Four years in a quality management role.

· Six years verifiable work experience.

· Accreditation experience.

· Two years managing personnel.

· Two years of research or document review.

· Experience working within cGMP program.

· Display a high level of attention to detail.

· Experience working in accordance with the ISO program

· Experience with FDA guidelines and protocol for cGMP

· Self-motivated and able to work independently and in a team setting

· Strong active listening and communications skills.

· Mathematics.

· Product quality.

· Cultivate safety first culture.

· Organized.

· Bachelor’s degree/High School Diploma

· Observe and follow company safety rules and regulations.

· Experience developing and delivering training for documentation and records management systems.

· Experience with vendor management is a pro.

· Well-organized and detailed oriented professional, with strong verbal and written communication skills.

· Excellent computer skills with working knowledge of MS office such as Word and Excel, Visio, and Adobe Acrobat professional.

· Good knowledge of ISO/SQF/FDA regulatory requirements

· Excellent written and verbal communication and negotiating skills

· Strong interpersonal skills

· Must be self-motivated with ability to handle, organize and prioritize multiple tasks and able to perform under pressure to meet deadlines.

· Ability to effectively participate on multi-disciplinary teams

Job Type: Full-time

Pay: $70,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Health insurance
• Paid time off

Schedule:

• 10 hour shift
• 8 hour shift
• Overtime

Education:

• High school or equivalent (Preferred)

Experience:

• Quality Assurance: 4 years (Preferred)
• ISO 9001: 2 years (Preferred)

Ability to Relocate:

• St. Louis, MO 63110: Relocate before starting work (Required)

Work Location: In person

Salary : $70,000 - $90,000