QA QC Associate II

Liquidyne Process Technologies, Inc; Wheat Ridge (CO); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

401K plan with Company Match

Personal Time off bank of 10 days and 6 sick days

10 Paid Holidays

Company HSA Contribution

Job summary

A leading technology company in Wheat Ridge, Colorado is seeking a Quality Assurance professional at the mid-senior level. The role involves reviewing documentation, ensuring quality standards, supporting audits, and maintaining compliance with regulations. A bachelor's degree in a science-related field and 3-5 years of relevant experience are required. The position offers benefits like a 401K plan, time off, and company contributions.

Qualifications

• Experience in cGMP manufacturing environments.
• At least 1-2 years of regulatory related background.

Responsibilities

• Review and approve documentation supporting production activities.
• Perform quality control checks for products.
• Generate and approve Certificates of Conformity.
• Support internal and external audit execution.
• Participate in investigations of quality issues.

Skills

Experience supporting audits (internal or external)

Experience with cleanroom environments

Experience with sterile/single use assemblies

Experience with Change Request and Change Notification

Ability to analyze data and identify root causes

Maintain positive and professional relationships

Ability to maintain confidentiality

Education

Bachelor’s degree in a science-related field

3-5 years of Quality Assurance experience

Job description

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.

Job Responsibilities

• 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.

Qualifications & Skills

• 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.

Education & Experience

• 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.

Benefits Package

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

Seniority Level

Mid-Senior level

Employment Type

Full-time

Job Function

Quality Assurance