Our client is a multi-billion-dollar eCommerce company with global operations in 21 countries and a strong, loyal customer base. With a focus on the personal wellness of their customers, our client manufactures and sells effective, high-quality, natural, health-oriented products, to help people live more vibrant, healthier, and happier lives. They are positioned to grow even more rapidly in upcoming years. With an overall mission of wellness and research into sustainable products, you will be a part of a mindful community of professionals, working to bring the enterprise to the cutting edge of technology.
We are searching for a QA Manager to supervise and direct quality audit activities. This QA Manager outlines, originates, and performs audits both internally, and with vendors to ensure compliance to company and regulatory guidelines. In addition to this, the QA Manager will lead efforts in process improvements related to audit findings.
- Coordinates internal audits of the plant(s) for compliance to Federal Food, Drug, and Dietary Supplement GMP laws and internal procedures.
- Coordinates vendor audits to assess their ability to comply with company specifications and meet GMP requirements.
- Assists QA manager/director during FDA and other regulatory agency inspections.
- Coordinates the audit of documentation and recommends document changes for the plant.
- Research possible causes and provides feedback regarding product quality issues raised by audits.
- Keeps current on regulatory actions in the Food, Drug, and Dietary Supplement industry.
- Writes internal and vendor audit reports.
- Works with vendors and purchasing to assure continuing conformance to specifications of incoming labels, components, ingredients, and outside-manufactured products.
- Keeps current on QA inspection results and procedures.
- Performs routine audits on historical batch records and other past OTC and DS documentation.
- Coordinates the yearly GMP awareness and compliance training.
- Bachelor’s degree with 8 years of manufacturing industry experience with at least 4 years experience with Quality Audits or working with vendors.
- Working knowledge of Federal Regulations regarding the manufacturing and distribution of drug products, Dietary Supplements, and Foods
- Experience with FDA audits is helpful.
- Excellent verbal and presentation skills.
- Ability to organize and coordinate projects.
- Ability to travel (maximum 15% of the time).
- Ability to write meaningful, accurate, and concise reports.
- Ability to perform multiple tasks in a fast-paced setting.
Just as important as your experience and skills will be the following characteristics and competencies:
- A natural orientation for continuous improvement and problem-solving.
- A collaborative approach and willingness to engage in an environment of active idea-sharing.
- Strong ability to multi-task in a fast-paced environment.
- The ability to produce consistent quality under deadline pressure while paying careful attention to detail.
- Performs other duties as assigned or needed.
- Provide supervision to QA associates as required by the position.
- Act as plant customer service liaison.
- Destruction or storage of outdated documents according to guidelines.
How does this benefit you?
- Our client has a GREAT CULTURE - flexibility is a must in this position; you'll become a part of a fast-paced team dedicated to a feel-good lifestyle brand dedicated to changing lives. Our client is proud to be part of a values-driven organization that treats employees with respect. Their employees and their families enjoy company parties and countless discounts around the community. They implement a very real open-door policy, and all employees are on a first-name basis—it feels more like a family than a multi-national corporation.
- Their location is Safe, uncrowded & affordable - nestled in the heart of beautiful Eastern Idaho, Idaho Falls is a prosperous and vibrant community, as well as the gateway to recreational paradise. This unique setting provides numerous opportunities for total wellness -- social, physical, financial, and emotional. If you love outdoor activities, this is the place for you, with the Snake River running right through town, the Rocky Mountains dominating the horizon, and Yellowstone less than a 2-hour drive away.
- Excellent compensation - in addition to a competitive wage, our client offers comprehensive benefits for their full-time employees that include all you would expect plus some remarkable surprises, such as a longevity bonus. They provide an onsite fitness center, free concierge service, and an employee restaurant.
We are well aware that talent comes in all sorts of different configurations. If you're wondering whether or not you're qualified, contact us directly so we can discuss your experience in more detail.
At Blackmere, we believe innovation and diversity go hand in hand. We are an equal opportunity employer and 100% committed to maintaining an inclusive and diverse Blackmere. We do not discriminate based on race, ethnicity, color, ancestry, national origin, religion, sex, sexual orientation, gender identity, disability, veteran status, genetic information, marital status, or any other legally protected status.