CleanWell is a botanically based cleaning products company recently relocated to Denver! We sell our own brand to various major retailers online and throughout the US. Additionally, we manufacture products for National and International brands across various channels. We are a small but rapidly growing company in need of filling a few key positions.
Job Title: Quality Assurance (QA) Associate
Reporting to: Regulatory & Quality Assurance (QA) Supervisor
Job Purpose: To perform activities that ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs, and our Standard Operating Procedures (SOPs).
Below is a description of the primary ongoing responsibilities of the Quality Assurance Associate role.
• Review, edit, and/or approve documents including Certificates of Analysis (Good Documentation Practices and Records Management Program)
• Ongoing review of current and future validation methods
• Work closely with Quality team to document Annual Product Reviews appropriately
• Work closely with Quality team to develop appropriate steps with OOS
• As needed, write up deviation investigations
• Perform activities associated with disposition of raw materials and finished product
• FDA Audit Document Coordinator
• As needed, maintain retain inventory including disposition of finished product
• Continually evaluating processes and procedures with an eye toward continuous improvement
Knowledge, Skills, and Abilities
• Good organizational skills and attention to detail
• Requires good written, verbal, and communications skills
• Ability to handle multiple assignments and changing priorities
• Ability to learn for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines as assigned
• Flexibility to work evenings and weekends during certain times, albeit minimal
• Understanding of manufacturing operations is preferred
Education and Experience
• Requires BS/BA in scientific discipline or related field with 0-5 minimum years of relevant experience in an FDA regulated company. Relevant experience may be substituted for education requirement