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Quality Assurance Supervisor

2 months ago

Pleasant Prairie, United States Concept Laboratories Full time $80,000 - $100,000
Job DescriptionJob Description

Job Description

 

Job Title:              Quality Assurance Supervisor                                     Department: QA

Reports to:         Director of Quality      

 

Note:  This position is training at our Chicago office but our business is moving to Pleasant Prairie WI   November of 2024. This will be where the position will be at.                                                  

 

Job Summary:

The QA Supervisor is responsible for ensuring timely and effective implementation of all company's policies, procedures, and activities involved in assuring the quality of manufactured products. Maintain close working relationships with other department managers and supervisory personnel in

order to meet and maintain product quality, identify, solve, and prevent problems affecting product quality, maximize productivity, and comply with regulatory requirements.

 

Supervisory Responsibilities:

·         Oversees the daily workflow of the department.

·         Provides constructive and timely performance evaluations. 

 

Duties/Responsibilities:

·         Supervise and direct quality assurance technicians/auditors who are responsible for enforcing cGMP and other quality-related policies in order to meet product quality standards.

·         Perform analytical testing when needed with instrumentation (GC, HPLC, FT-IR, UV-Vis, etc.).

·         Review Production Batch Records and other manufacturing-related documents to verify compliance, integrity and record keeping for all mandated manufacturing processes, quality checks, testing, sampling, and sanitation activities.

·         Assist in the coordination of testing results involving finished products, raw materials, and packaging components and the appropriate release and hold programs associated with these materials.

·         Oversee the “On Hold” product program, including the status, release, and destruction of “Rejected” products.

·         Processes, distributes, and maintains controlled documentation (i.e., SOPs, WI, copacker technical manual, change control tracking, material specification, logbooks, etc.) using a document control system.

·         Assist in the investigation and review of deviations, change controls, CAPAs and OOS reports to assure complete compliant source data.

·         Audit quality control of raw materials, packaging components, labels, and finished products to ensure compliance with established specifications and regulatory standards.

·         Follow up with implemented programs (GMPs, ISO, Cleaning and Sanitation, Pest Control, Equipment Calibration, etc.) to ensure compliance by employees and other personnel in the manufacturing facility.

·         Assist in investigating and correcting quality-related issues (including customer complaints) through collaboration with other departments.

·         Make proactive recommendations and offering/presenting solutions to the Quality Systems & Regulatory Compliance Department Management to improve quality and work efficiency.

·         Assist in the implementation of policies, operating procedures, quality systems and programs which ensure proper testing, evaluation, inspection, and technical support in order to meet product quality standards.

·         Orders supplies, submits purchasing orders, and processes departmental invoices.

·         Assists with internal audits and collecting documentation and tracking during audits.

·         Assists with tracking training completions and uploading of QA training records.

·         Adheres to policies, procedures, SOP's, safe work practices, and safety policies and procedures.

·         Communicates concerns to supervisor, reports hazards, and provides input on prevention.

·         Initiate non-conformance investigations.

·         Demonstrate strong organization skills related to priorities and workload.

·         Compile and communicate performance metrics and data trend analyses to senior management for Batch Review and Release relevant activities.

·         Identify opportunities for improvement within scope of work.

·         Serves as change agent for continuous improvement in operational excellence activities.

·         Provide logistical support and technical knowledge during regulatory and internal inspections of Company quality systems.

·         As needed, other administrative duties may be assigned by the Quality Assurance Management team.

 

Required Skills/Abilities:

·         Excellent verbal and written communication skills.

·         Analytical chemistry skills, involving instrumentation and method development.

·         Strong mathematical, analytical, and problem-solving skills.

·         Ability to speak and write effectively and strong ability to collaborate with others to complete assigned tasks.

·         Proficient with Microsoft Office Suite or related software.

·         Working Knowledge of cGMP, FDA regulations and ISO standards

·         Excellent organizational skills and attention to detail.

·         Excellent time management skills with a proven ability to meet deadlines.

·         Strong supervisory and leadership skills.

·         Ability to prioritize tasks and to delegate them when appropriate.

·         Ability to function well in a high-paced and at times stressful environment.

·         Ability to learn quickly, work independently, prioritize, and assume responsibility for new tasks in a rapidly growing and changing company.

·         Must be able to work a flexible schedule, including off shifts and weekends as needed.

 

Education and Experience:

EDUCATION and EXPERIENCE:  Four (4) year bachelor’s degree in a science field (chemistry, biology, etc.) and a minimum of five (5) years experience in Quality Assurance (preferably cosmetics, biologic, medical device, or pharmaceutical industries).

 

Physical Requirements:

Prolonged periods of sitting at a desk and working on a computer.

Must be able to lift up to 15 pounds at times.

Company DescriptionConcept Laboratories, Inc., a 30-year-old, Chicago based personal care and skincare manufacturer, is looking for a candidate to California team. This position provides a unique opportunity to learn under a team with over fifteen years of combined experience while offering hands-on experience in a rapidly growing industry. We have grown tremendously in the past two years and are moving our manufacturing facility to Pleasant Prairie WI. January 2025. This position as Regulatory Assistant would reside in California Office and we offer a flexible schedule with remote 2 days and in office 3 days.Company DescriptionConcept Laboratories, Inc., a 30-year-old, Chicago based personal care and skincare manufacturer, is looking for an intern to join our e-commerce sales and marketing team for the summer. This position provides a unique opportunity to learn under a team with over fifteen years of combined e-commerce experience while offering hands-on experience in a rapidly growing industry. We have grown tremendously in the past two years and are moving our manufacturing facility to Pleasant Prairie WI. January 2025. This position would reside in our Chicago office.