Apply on Employer Site

iLABS (Innovation Labs) Inc. · 17 hours ago

Quality Assurance Supervisor

Mahwah, NJ

Full-time

Onsite

Senior Level

$60K/yr - $70K/yr

5+ years exp

iLABS (Innovation Labs) Inc. is seeking a Quality Assurance Supervisor to manage compliance activities following their policies and regulatory standards. The role involves supervising the Quality Compliance group, ensuring adherence to FDA and Health Canada regulations, and leading investigations and corrective actions to maintain compliance.

CosmeticsManufacturingProduct ResearchWellness

H1B Sponsor Likely

Responsibilities

Supervises and manages the activities of the Quality Compliance group. Assures job objectives are met on a timely basis

Leads team members in the deviation investigation process

Ensures appropriate CAPAs are generated to increase compliance and prevent repeat occurrences of deviations

Ensures control of systems, processes, and products through supporting review and approval of change notices and change control

Responsible for scheduling and execution of the site internal auditing program assuring CAPAs are completed promptly

Ensure compliance with all relevant ISO and FDA GMP regulatory requirements (ISO 22716, 21 CFR Parts 210 and 211)

Assures standard operating procedures (SOPs) related to job responsibilities define the steps necessary to complete tasks, etc

Writes, reviews and updates SOPs while managing archival of batch records and GMP documentation for the site

Collecting, collating and evaluating scientific data that has been researched by colleagues and providing strategic advice to senior management

Project managing teams of colleagues involved with the development of new processes and procedures

Reviewing company practices and providing advice on changes to systems

Provides administrative support by implementing systems, procedures, and policies; completing projects in support of compliance auditors

Complies with federal, state, and local legal requirements by studying existing and new legislation; enforcing adherence to requirements; advising management on needed actions

Collaborates with other departments to direct compliance issues to appropriate existing channels for investigation and resolution

Responds to alleged violations of rules, regulations, policies, procedures, and Standards of Conduct by evaluating or recommending the initiation of investigative procedures. Develops and oversees a system for uniform handling of such violations

Acts as an independent review and evaluation body to ensure that compliance Issues/concerns within the organization are being appropriately evaluated, investigated and resolved

Monitors, and as necessary, coordinates compliance activities of other departments to remain abreast of the status of all compliance activities and to identify trends

Identifies potential areas of compliance vulnerability and risk; develops/implements corrective action plans for resolution of problematic issues, and provides general guidance on how to avoid or deal with similar situations in the future

Provides reports regularly, and as directed or requested, to keep senior management informed of the operation and progress of compliance efforts

Responsible for assisting with developing, reviewing, and executing validations to maintain Compliance with FDA and CGMP regulations

Performs additional assignments and responsibilities as determined by Vice President of Quality

Qualification

GMP knowledgeQuality risk managementRegulatory complianceBachelor's DegreeCoaching othersBilingual in English & SpanishConflict managementBuilding relationships

Required

Must have a Bachelor's Degree in Chemistry, Biology, Environmental Sciences, or related field of study

Minimum 5 years related experience or equivalent

Must have GMP, Quality, and in-depth risk management knowledge

Must be able to interpret problems and effectively prepare surrounding communication in a productive manner to management with clarity and accuracy

Must have strong authorship and be able to critically review investigations with Quality risk management principles

Must be skilled in planning and organizing, conflict management, coaching others, talent selection, developing others, decision making and building relationships

Manages positive relationships with external customers

Preferred

Bilingual in English & Spanish is preferred

Benefits

Comprehensive Health Benefits package (Medical, Dental, Vision, Life, AD&D)

Competitive 401(k) match with immediate vesting

Paid time off (Vacation, Sick, Holiday, Summer Fridays)

Monthly birthday celebrations + other fun activities!

Daily subsidized meals

Company

iLABS (Innovation Labs) Inc.

iLABS is the first global innovation company of its kind in the beauty industry to develop alliances with the most creative chemists and scientists from around the world and then introduce these innovations and ideas to beauty brands, eager for new and amazing formulas and products.

Founded in 2019

Mahwah, New Jersey, USA

51-200 employees

https://ilabsus.com

H1B Sponsorship

iLABS (Innovation Labs) Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2023 (2)