Quality Specialist Jobs

A bit about Health & Happiness

At Health & Happiness (H&H), our vision is focused on premium nutrition and lifetime wellness; to inspire and achieve this vision we bring together seven international brands as we strive to make people around the world healthier and happier. We have established market positions in more than 15 countries in Asia-Pacific, Europe, North America and Oceania with more than 3,400 employees working across the globe. We are excited about our future as we expand these premium, proven and aspirational brands to new markets, greeting consumers in all life stages.

What this means for you

The variety of work creates unlimited opportunities to excel across a breadth of disciplines; you will be presented with a wealth of new pathways and opportunities to explore throughout your career. Working with us will be more than just a job; we guarantee a life-changing experience as you step into an environment that moves quickly and presents new challenges daily.

Our success as an organization is directly attributed to the health and happiness of our team. As a new team member, you will be empowered to positively contribute to our high-impact culture and be supported in bringing your whole self to work.

Your role within the team

The Quality Control Specialist is responsible for routine submission of finished product samples to 3rd party laboratories; includes tracking and review lab reports.

Provides daily and weekly updates to the leadership team regarding the status of finished product samples undergoing testing. Communicates OOS (out of specification) failures to the team and the Quality Assurance Specialist for MRB (Material Review Board) review.

Support cross-functional teams on lab target releases, vendor audits and escalates priorities to leadership. The Quality Control Specialist must be detail-oriented with capability of working cross-functionally in a fast-paced environment with both internal and external customers.

Duties and responsibilities

• Participates in the Material Review Board and Document Control Review Board meetings.
• Other supportive duties and responsibilities as assigned
• Responsible for creating and maintaining reports including but not limited to quality data trending, COA on shared drive, ingredients test informational spreadsheets, laboratory log spread sheets, etc…
• Ensure certifications for loggers & scale are current
• Prepares and submits samples to the appropriate 3rd party laboratory testing facility for New Product Development, R&D prototypes, and quality finish product samples.
• Track all stability reports are received at designated intervals and testing compliance at each designated timepoint, review reports. Notify management when any tests do not meet specifications.
• Responsible for providing status updates to other departments regarding sample submission (Product Development, Contract Manufacturer).
• Manage OOS (out of specification) investigations for all products that fail to conform to specification, complete report.
• Works closely with the Co-manufacturers, Product Development, Regulatory staff to resolve quality issues regarding product testing
• Evaluate product formula ingredients, analytes, overages, and determine testing capabilities and appropriate testing methods by working with the 3rd party laboratories and cross-functional teams
• Develop/maintains stability program with finished product samples sent to vendor conducting stability tests. Prepare stability protocol with addendum to stability vendor that outlines test program. Obtain quotes prior to testing for review my management.
• Track all finished product releases with status monthly by vendor and product for management.
• Review and approves monthly lab invoices for AP and tracks all lab related costs monthly.
• Reviews COA (Certificate of Analysis) from raw material suppliers, Co-Manufacturers, 3rd Part Laboratory testing, with approval/non-approval notifications to all parties.
• Review and maintain the temperature and relative humidity loggers and communicate any outliers to management
• Communicates notification to supply chain, operations, and leadership teams of release when results conform to specification and when out of specification.
• Support and participate in training on applicable SOPs, regulatory requirements, and quality initiatives
• Follows and complies with approved regulatory policies and standard operating procedures, GMP 21 CFR 111, 21 CFR 117, 21 CFR 507, or any other law, rule, or regulation.
• Conduct review of raw materials and finished products within two days receipt of COA.
• Maintain COAs (Certificate of Analysis) on the company network drive.
• Work closely with team to inspect, record, and maintain retain samples to ensure compliance with cGMPs including but not limited to an annual inventory audit
• Schedule Temp & RH loggers and scale for yearly inspection for calibration

Desired Skills and Experience

• Utilize decision-making skills to consider the relative costs and benefits of potential actions with recommendations to management.
• Minimum one year of direct experience in the dietary supplement industry with 21 CFR 11, 21 CFR 111, and 21 CFR 117 experience
• Computer literate and familiar with Microsoft office (Word, Excel, PowerPoint)
• Bachelor’s degree in Science or Engineering
• Vigorous attention to detail
• Excellent communication (written, oral, interpersonal) and grammar skills.
• The ability to work autonomously and with as a team member with accountability.
• Ability to balance multiple tasks and prioritize tasks.
• Knowledge of the Dietary Supplement Health & Education Act (DSHEA) will be critical to success in this role.
• Energy and enthusiasm to develop processes from the ground up, drive and track tasks, and identify opportunities for continuous improvement process.

At H&H Group, we believe an equitable and inclusive work environment and a diverse, empowered team are key to achieving our mission. We’re not looking for candidates who are “culture fits.” We’re looking for candidates who can expand our culture and challenge business as usual. We strive to foster an environment where all staff can bring their whole selves to work, by their own definition, and we strive to provide all candidates with an equitable and accessible recruitment process.

We provide equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, sexual orientation, gender identity or expression, veteran status, or genetics.

In addition to federal law requirements, we comply with applicable state and local laws governing non discrimination in employment in every location in which the company has facilities.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

If we can offer accommodations for you in the recruitment process, or if you have feedback on how to make our recruiting more equitable or accessible, please let us know!