Senior Quality Assurance Compliance Specialist, Qunol

Senior Quality Assurance Compliance Specialist, Qunol

Location: Pinebrook, NJ (hybrid)

Opella is the self-care challenger with the purest and third-largest portfolio in the Over-The-Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally. 

Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting.

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.

About the Job

The Senior Quality Assurance Compliance Specialist will report to the Quality Assurance Senior Manager. This position will be responsible for reviewing and approving customer complaints, performing and organizing training for employees, investigating and writing deviations and Out of Specification reports, reviewing and approving supplier investigations and corrective actions, and writing and editing Standard Operating Procedures and specifications.

Main Responsibilities:

• Review customer complaints and identify appropriate next steps
• Communicate with impacted partners and ensure timely response
• Critically assess and approve supplier responses to complaints
• Partner with Customer Service on any customer communications as needed
• Partner with all internal departments to develop training matrix by individual / function
• Maintain training matrix and assign trainings to new and existing employees per training matrix
• Act as a Quality Champion to reinforce the importance of Quality throughout the organization
• Perform investigations using appropriate methodology to ensure complete investigation (i.e., Fishbone or 5 Why’s) and write deviations and investigations as needed.
• Partner with suppliers as needed to ensure thoroughness of investigations and timeliness of responses
• Write deviations and investigations to capture findings and root causes.  Assign corrective and preventive actions as appropriate.
• Follow up with suppliers as needed to ensure effectiveness of corrective actions
• Draft new SOPs and edit existing SOPs as needed
• Partner with internal departments to ensure SOPs are appropriate and effective
• Review SOPs as needed to ensure they are still current
• Draft/Review/Edit existing in-house and supplier specifications
• Support any outside regulatory audits
• Develop and manage an audit readiness process
• Identify areas of risk in the organization and partner with the organization to mitigate any potential risks

About You:

• Bachelor's degree or related experience in a technical field
• 5-10 years of Quality Compliance experience
• Knowledge and experience working under GDP/cGMP, FDA or some other regulated field preferred
• Knowledge of Dietary Supplement requirements specified under CFR 111, preferred
• Able to work independently and manage day-to-day workload with minimal supervision
• Basic knowledge of continuous improvement principles and practices
• Good written and oral communication skills in English.
• Experience with performing and writing deviations, investigations and Out of Specification reports
• Highly organized, detailed and result oriented
• Critical thinker who can ensure quality standards while still supporting the needs of the business
• Ability to develop partnerships both internally as well as externally to ensure quality is integrated throughout the organization
• Demonstrated problem-solving skills and techniques commensurate with job level
• Strong team player that can also work independently to achieve objectives
• Proven ability to work effectively in a fast-paced team environment
• Computer skills including MS Office products required, ideally experienced using Quality documentation software

Why us?

At Opella, you will enjoy doing challenging, purposeful work, empowered to develop consumer brands with passion and creativity. This is your chance to grow new skills and be part of a bold, collaborative, and inclusive culture where people can thrive and be at their best every day.

We Are Challengers.

We are dedicated to making self-care as simple as it should be. That starts with our culture. We are challengers by nature, and this is how we do things:

All In Together: We keep each other honest and have each other's backs.

Courageous: We break boundaries and take thoughtful risks with creativity.

Outcome-Obsessed: We are personally accountable, driving sustainable impact and results with integrity.

Radically Simple: We strive to make things simple for us and simple for consumers, as it should be.

Join us on our mission. Health. In your hands.

www.opella.com/en/careers

Opella Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

North America Applicants Only

The salary range for this position is: $110,000.00 - $130,000.00

All Compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the Link.

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