Job Description

Quality Systems Specialist

Job Overview:
The Quality Systems Specialist will work within the Quality team and play a vital role in the creation and evaluation of all the Company\xe2\x80\x99s quality systems. The Key Objective of the Quality Systems Specialist is to ensure that all Company\xe2\x80\x99s Production Quality systems meet and are delivering against all regulatory requirements. They will provide support for Client Service/Business Development teams from initial product qualification followed to first phase of production. They will interact with production and engineering personnel to set up production test requirements and new product qualifications.

Responsibilities:

• This position performs a wide variety of duties. This position supports the daily QA departmental operations and assists the Compliance/Regulatory Manager in ensuring compliance in all areas. The Quality Assurance Specialist is responsible for supporting the Quality System in conjunction with client needs and requirements to ensure compliance to FDA CFR 110, 111, 117, 210 & 211 and customer specific requirements.
• Provide Quality support for all new client management and managing all product launches and new product SKU\xe2\x80\x99s as well as, all special projects. This person will assist in evaluating all new client and product prospects to determine specific registration, certification, and license requirements. This will be completed alongside the Compliance/Regulatory Manager.
• Develop and oversee all Stabilities and Validation activities; IQ/OQ/PQs for equipment, cleaning, or other special project protocols.
• Lead equipment calibration process.
• Update and create Standard Operating for Quality Assurance related activities.
• Conduct internal and external audits to effectively monitor and enforce compliance with the company\xe2\x80\x99s SOPs and cGMPs.
• Oversee the HAACCP (Hazard Analysis and Critical Control Points) Program.
• Manage activities related to external labs and consultants.
• Review and approve lab reports and ensure consistency with MP standards.
• Responsible for environmental program cleaning validation and pathogen detection
• Perform Risk Assessment for new product and Annual Review for Environmental Monitoring Program, Cleaning Validation and Pathogen Detection Programs.
• Oversee CAPA process with emphasis on timely completion of tasks.
• Deliver and update reports related to KPIs.
• Oversee the Pest Control Programs, providing monthly updates of any inconsistencies.

• Provide administrative/technical support to the Compliance/Regulatory Manager and the Quality Team.
• Assist with FDA and other regulatory agency inspections.
• Assist the QA Specialist in drafting and/or writing change controls, complaints, deviation, and investigation reports.
• Maintain an organized workplace.

• HS diploma. BS degree in a scientific field is strongly preferred.
• 5+ years of experience in the nutritional supplement and/ or food manufacturing industry.
• Knowledge of cGMP regulations and guidelines and QA best practices preferred.
• Experience working with Contract Packaging Organizations a must.
• Validation experience strongly preferred.
• Excellent technical writing skills a must.
• Demonstrated experience with Quality Systems preferred.
• Must be self-motivated and able to work independently but maintain a team focused attitude.
• Excellent attention to detail and follow-through and organizational skills.
• Excellent verbal, written, and interpersonal communication skills.
• Ability to motivate and build strong relationships with internal team members as well as with clients, when required.
• Proactive thinker. Ability to identify potential issues beforehand and raise them to management with possible solutions.
• Strong desire to learn.

• Must be able to remain in the stationary position 70% of the time.
• The person in this position may need to frequently move about inside the office and on the production floor.
• The person in this position is required to communicate with all other departments and must be able to exchange accurate information in these circumstances.

CommTech