What are the responsibilities and job description for the Quality Manager position at vvf intervest, llc?
General Overview
The quality manager is responsible for the planning and creating processes of quality systems that align with our customers’ requirements as well as directing Quality activities in compliance with cGMP, FDA and other regulatory requirements.
Key Responsibilities
- Develops and maintains quality assurance programs, policies, processes, procedures and controls ensuring that performance and quality of products conform to established standards and agency guidelines to ensure customer satisfaction.
- Provides expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance.
- May serve as liaison between the company and the various governmental agencies.
- Assists with the development of control systems for new processes and products.
- Establishes policy and strategy during new product start-ups.
- Verifies process validation studies are conducted correctly and creates validation documentation for any OTC products.
- Primary contact for all formula updates and revised raw material specifications received from
Customers.
- Works directly with operations to ensure that inspections, statistical process control analyses and audits are conducted as specified to enforce requirements and meet specifications. Responsible for administrating inspection procedures and standards.
- Establishes and ensures that inspections are conducted prior to the processing of raw materials, ingredients, and product and packaging specifications.
- Investigates customer complaints and provides direction for the resolution of quality related issues.
- Meets department financial objectives through the development and management of annual budget.
- Identifies department goals and delivers results tied to departmental and plant goals
- Manages and develops direct reports by through goal development, addressing performance and identifying training.
- Ensures timely completion of all required departmental and plant safety training. Ensures a safe working environment.
Qualifications
Basic Minimum Requirements
- Meet the legal minimum age requirement.
- Authorized to work in the United States.
- BS Degree in Chemistry, or Biology, or Engineering or related field.
- 5 years of experience in a FDA regulated manufacturing environment.
- 5 years of experience working in a Quality environment with comprehensive knowledge of cGMP and FDA regulations.
- Experience managing direct reports.
- Experience conducting/managing internal and external quality audits, FDA audits, customer audits.
- Advanced skills in Microsoft Office (Outlook, Word, Excel, and Power Point).
Other Required Skills
- Ability to work independently and as part of a team.
- Strong attention to detail, planning and organizational skills.
- Strong written, verbal and interpersonal skills.
Preferred Qualifications:
- Six sigma certification.
- Experience in a high-speed packaging environment working with injections molded plastics, overwrap films and corrugate components.
Physical Demands:
- Able to sit for long periods of time utilizing a computer.
- Able to stand for long periods of time.
- Exposure to dust, noise and odors.
- Work may be performed in a manufacturing environment.
- Lifting up to 20 lbs.
Note:
The above statements shall not be construed as a complete description of all the work requirements.
VVF is an equal opportunity employer. We evaluate qualified applicants, without regard to race, color, religion, national origin, sex or gender, age, disability, veteran status, sexual orientation, gender identity or expression, genetic information, including the perception that a person has any of those characteristics or that the person is associated with a person who has, or is perceived to have, any of those characteristics, or any other consideration made unlawful by applicable law. VVF is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please call Human Resources at (630) 801- 5012 and let us know the nature of your request and your contact information.