QA QC Associate II

Liquidyne Process Technologies, Inc., founded in 1993, is a leading distributor and fabricator of innovative solutions for fluid transfer, measurement and control. Liquidyne is a dynamic, growing organization located in the beautiful Golden area of Colorado. We serve the Life Sciences, Food & Beverage, Commercial & Industrial markets with a focus on the Biopharmaceutical, Pharmaceutical, Nutraceutical, Animal Health, & Cosmetics industries.

• Review and approve completed documentation including batch records and logs to support production activities.
• Perform quality control checks as defined by internal procedures for products produced, including review/inspection of the product, associated labels, and other items as described.
• Generate and perform final approval on Certificates of Conformity (CoC) for products produced, including review of testing and gamma irradiation documentation for sterile single use products.
• Participate in the review and approval for new product requests in collaboration with Operations & Engineering staff, obtaining, reviewing, and maintaining the necessary validation paperwork provided by suppliers.
• Participate in the creation, review, and approval of changes to products, processes, and documents to ensure internal and external regulations are met.
• Provide guidance during new product development and product changes for applicable regulatory requirements.
• Create and maintain appropriate documents for quality processes such as procedures, instructions, validation protocols/reports, site master validation plan, etc.
• Participate in investigations when quality issues are identified through internal or external methods, guiding the team through root cause investigations and implementation of corrective actions.
• Support internal and external audit execution for customer, supplier, and internal audits.
• Support vendor approval process to determine necessary requirements of vendors based on the product/service provided.
• Provide customer facing documents such as client surveys, evidence of quality systems, etc.
• Develop and implement plan to put cGMP principles into practice based upon applicable sections of FDA 21 CFR 820 and/or ISO 13485.
• Routinely prioritize competing business interests and prioritize project initiation through completion.
• Provide company management with key projects that can be executed with given resources to provide financial benefit and increased efficiency annually.
• Make timely decisions in the company's best interest.

• Experience supporting audits (internal or external).
• Experience with cleanroom environments including the controls required.
• Experience with sterile/single use assemblies.
• Experience with Change Request and Change Notification.
• Demonstrated ability to analyze data and identify root causes of quality issues.
• Maintain positive and professional relationships both internally and externally.
• Ability to maintain confidentiality for customers.

• Bachelor’s degree in a science related field (biology, chemistry).
• Minimum 3-5 years of Quality Assurance experience, including at least 1-2 years of regulatory related background within cGMP manufacturing environments.

• 401K plan with Company Match
• Personal Time off bank of 10 days and 6 sick days
• 10 Paid Holidays
• Company HSA Contribution

Mid-Senior level

Full-time

Quality Assurance