Senior Quality Assurance Compliance Specialist, Qunol

Opella•Pine Brook, NJ

4d•$110,000 - $130,000•Hybrid

About The Position

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.

Requirements

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

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