Role Overview

The Quality Control Specialist is responsible for routine submission of finished product samples to 3^rd 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, 3^rd 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 3^rd 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 3^rd 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 in this role.

Preferred:

• 3 years of direct experience in the dietary supplement industry with 21 CFR 11, 21 CFR 111, and 21 CFR 117 experience
• Experience with Pet supplements
• Highly proficient with Microsoft Project, Microsoft Excel, Word, Outlook, and Google Docs.
• Knowledge of raw materials, production processes, lab testing, and quality control.

Job Demands:

• Must be able to remain in a stationary position sitting most of the time (95%). Walking and standing are required only occasionally (5 %)
• The person in this position needs to occasionally move about inside the office to access file cabinets, office machinery, office supplies etc.
• Exerting up to 10 pounds of force occasionally and/or negligible amount of force to lift, carry, push, pull or otherwise move objects, including the human body.
• Constantly operates a computer and other office productivity machinery such as a copy machine, computer printer and a calculator.
• The worker is required to have close visual acuity to perform an daily tasks such as: preparing and analyzing data in reports; viewing a computer terminal; extensive reading.
• The person in this position frequently communicates to other workers orally and in writing.
• Ability to receive detailed information through oral communication.
• Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers in order to operate a computer or other office equipment.

About us

Zesty Paws is growing faster than we planned. The demand for first-time and repeat purchases are both energizing and overwhelming. The truth is, we need help, and we are hoping you can help us.

Every day at Zesty Paws has new challenges, seriously. Today, we are an organization of people who "figuring it out." We get it done. We often find ourselves pushing the boundaries of prix fixe job descriptions' responsibilities. And, we often do it with our might. We're looking for brilliant, talented people who are self-learns and can solve first-time problems independently. Dealing with this sort of ambiguity is more than a skill or an experience you once had; the right person will feel forward-driving excitement from this environment, not paralyzing frustration. If you're that right person, you've been hard to find. That's why we pay better than three out of four companies. That's why our benefits are so great! We hope you'll consider joining our team!