Quality Control Specialist

Role Overview

The Quality Control Specialist is responsible for routine submission of finished product samples to 3rd party laboratories; includes tracking and review lab reports. 

Provides daily and weekly updates to the leadership team regarding the status of finished product samples undergoing testing. Communicates OOS (out of specification) failures to the team and the Quality Assurance Specialist for MRB (Material Review Board) review.

Support cross-functional teams on lab target releases, vendor audits and escalates priorities to leadership. The Quality Control Specialist must be detail-oriented with capability of working cross-functionally in a fast-paced environment with both internal and external customers. 

Responsibilities

• Responsible for providing status updates to other departments regarding sample submission (Product Development, Contract Manufacturer).
• Responsible for creating and maintaining reports including but not limited to quality data trending, COA on shared drive, ingredients test informational spreadsheets, laboratory log spread sheets, etc…
• Reviews COA (Certificate of Analysis) from raw material suppliers, Co-Manufacturers, 3rd Part Laboratory testing, with approval/non-approval notifications to all parties.  
• Maintain COAs (Certificate of Analysis) on the company network drive.
• Conduct review of raw materials and finished products within two days receipt of COA.
• Prepares and submits samples to the appropriate 3rd party laboratory testing facility for New Product Development, R&D prototypes, and quality finish product samples.
• Communicates notification to supply chain, operations, and leadership teams of release when results conform to specification and when out of specification.
• Track all finished product releases with status monthly by vendor and product for management.
• Develop/maintains stability program with finished product samples sent to vendor conducting stability tests. Prepare stability protocol with addendum to stability vendor that outlines test program.  Obtain quotes prior to testing for review my management.
• Track all stability reports are received at designated intervals and testing compliance at each designated timepoint, review reports.  Notify management when any tests do not meet specifications.
• Manage OOS (out of specification) investigations for all products that fail to conform to specification, complete report.  
• Works closely with the Co-manufacturers, Product Development, Regulatory staff to resolve quality issues regarding product testing
• Evaluate product formula ingredients, analytes, overages, and determine testing capabilities and appropriate testing methods by working with the 3rd party laboratories and cross-functional teams
• Review and approves monthly lab invoices for AP and tracks all lab related costs monthly.
• Work closely with team to inspect, record, and maintain retain samples to ensure compliance with cGMPs including but not limited to an annual inventory audit
• Review and maintain the temperature and relative humidity loggers and communicate any outliers to management
• Ensure certifications for loggers & scale are current
• Schedule Temp & RH loggers and scale for yearly inspection for calibration
• Follows and complies with approved regulatory policies and standard operating procedures, GMP 21 CFR 111, 21 CFR 117, 21 CFR  507, or any other law, rule, or regulation.
• Support and participate in training on applicable SOPs, regulatory requirements, and quality initiatives
• Participates in the Material Review Board and Document Control Review Board meetings.
• Other supportive duties and responsibilities as assigned

Job Knowledge, Skills and Abilities:

Required:

• Bachelor’s degree in Science or Engineering
• Minimum one year of direct experience in the dietary supplement industry with 21 CFR 11, 21 CFR 111, and 21 CFR 117 experience
• Computer literate and familiar with Microsoft office (Word, Excel, PowerPoint)
• Excellent communication (written, oral, interpersonal) and grammar skills.
• Energy and enthusiasm to develop processes from the ground up, drive and track tasks, and identify opportunities for continuous improvement process.
• Vigorous attention to detail
• The ability to work autonomously and with as a team member with accountability.
• Ability to balance multiple tasks and prioritize tasks.
• Utilize decision-making skills to consider the relative costs and benefits of potential actions with recommendations to management.
• Knowledge of the Dietary Supplement Health & Education Act (DSHEA) will be critical to success