Quality Assurance Supervisor

Elevation Labs•Idaho Falls, ID

About The Position

The Quality Assurance Supervisor helps to provide oversight and guidance to personnel while focusing on supervising the processes in the Quality Assurance Unit including document review and control, regulatory compliance, internal auditing, CAPA and Deviation program management, and product release for cosmetic, personal care, OTC drug, and medical device manufacturing. This includes but is not limited to: Essential Functions, Key objectives, and Responsibilities: Supervise and provide guidance to Quality Assurance personnel. Work in ISO 22716, ISO 13485, and FDA regulated environment. Maintain Quality Manual, SOP's, and review / revision of various GMP and ISO documents. Assist with APR's (Annual Product Reviews) for OTC and medical devices. Support Environmental testing and monitoring program of the facilities and controlled environment. Participate in CAPA, Root Cause Analysis, and Change Control activities. Review / participate in rework charters, NCRs, and OOS investigations as needed. May assist with Customer Complaint investigations. Review and verify QC testing procedures and results including logbook reviews. Participate in internal audits and support external Customer and Regulatory audits. Assist with training for quality personnel and other business units as needed including GMP annual training and orientation training. Perform job closeout activities, verify lot codes, and perform batch release. Participate in Lean initiates, GEMBA walks, and other process improvement activities. Other duties as assigned. Required Knowledge, Skills, And Competencies: Ideal Candidate Qualifications: Background in Quality Assurance, Quality Control, or related fields. Knowledge of GMP requirements pertaining to the personal care, OTC, and/or Medical Device industry. High attention to detail, organization, and time management. Able to communicate effectively in writing and verbally in the English language. Good communication skills are required. Must be able to effectively and professionally communicate deviations and other information necessary for compliance. Must be able to perform mathematical calculations and verify accuracy of calculations. Knowledge of lean manufacturing principles and other continuous improvement tools. Able to perform basic investigation functions and manipulate information effectively. Operate computer applications (i.e., Microsoft applications, ERP system, lab software, etc.). Perform essential duties and responsibilities efficiently and accurately with minimal supervision. Education/Experience: College degree (A.S. or B.S.) in Biology, Chemistry, or related field and/or 5+ years of relevant experience in quality assurance or laboratory setting required. Experience within the personal care/cosmetic, OTC drug, or medical device industry preferred. Physical/Mental Demands: Regularly/Frequently required to sit, stand, walk, stoop, kneel, or bend. Must be able to move between facilities on our campus. Regularly/Frequently use hands to keyboard or type, handle materials, or manipulate tools. Occasionally/Frequently lift and/or move up to 25 pounds and, infrequently, up to 50 pounds. Specific vision abilities required by this classification include close vision, depth perception, color determination, and ability to adjust focus. Must be able to communicate effectively in person, by telephone, and via messaging. Requires composure and ability to prioritize and handle many urgent tasks and requests simultaneously with a high level of competence and accuracy. Maintain confidentiality.

Requirements

Background in Quality Assurance, Quality Control, or related fields.
Knowledge of GMP requirements pertaining to the personal care, OTC, and/or Medical Device industry.
High attention to detail, organization, and time management.
Able to communicate effectively in writing and verbally in the English language.
Good communication skills are required.
Must be able to effectively and professionally communicate deviations and other information necessary for compliance.
Must be able to perform mathematical calculations and verify accuracy of calculations.
Knowledge of lean manufacturing principles and other continuous improvement tools.
Able to perform basic investigation functions and manipulate information effectively.
Operate computer applications (i.e., Microsoft applications, ERP system, lab software, etc.).
Perform essential duties and responsibilities efficiently and accurately with minimal supervision.
College degree (A.S. or B.S.) in Biology, Chemistry, or related field and/or 5+ years of relevant experience in quality assurance or laboratory setting required.
Regularly/Frequently required to sit, stand, walk, stoop, kneel, or bend.
Must be able to move between facilities on our campus.
Regularly/Frequently use hands to keyboard or type, handle materials, or manipulate tools.
Occasionally/Frequently lift and/or move up to 25 pounds and, infrequently, up to 50 pounds.
Specific vision abilities required by this classification include close vision, depth perception, color determination, and ability to adjust focus.
Must be able to communicate effectively in person, by telephone, and via messaging.
Requires composure and ability to prioritize and handle many urgent tasks and requests simultaneously with a high level of competence and accuracy.
Maintain confidentiality.

Nice To Haves

Experience within the personal care/cosmetic, OTC drug, or medical device industry preferred.

Responsibilities

Supervise and provide guidance to Quality Assurance personnel.
Work in ISO 22716, ISO 13485, and FDA regulated environment.
Maintain Quality Manual, SOP's, and review / revision of various GMP and ISO documents.
Assist with APR's (Annual Product Reviews) for OTC and medical devices.
Support Environmental testing and monitoring program of the facilities and controlled environment.
Participate in CAPA, Root Cause Analysis, and Change Control activities.
Review / participate in rework charters, NCRs, and OOS investigations as needed.
May assist with Customer Complaint investigations.
Review and verify QC testing procedures and results including logbook reviews.
Participate in internal audits and support external Customer and Regulatory audits.
Assist with training for quality personnel and other business units as needed including GMP annual training and orientation training.
Perform job closeout activities, verify lot codes, and perform batch release.
Participate in Lean initiates, GEMBA walks, and other process improvement activities.
Other duties as assigned.