QC Associate II

AdientOne Consulting; California (MO); On-site; USD 65,000 - 90,000; Full time

Job summary

AdientOne Consulting seeks a QC Analyst to perform routine and non-routine testing in a multi-product pharmaceutical QC lab. The role involves technical review, trend analysis, and investigations of atypical results, with QA support during audits and inspections.

You will participate in risk assessments and validation activities for non-routine equipment and contribute to process improvements while maintaining strict cGMP compliance. Bachelor’s in Biology or Life Sciences required.

Qualifications

• 3–5 years of GMP experience preferred.
• Strong interpersonal and written/oral communication skills.
• Able to interact with multiple departments and levels.

Responsibilities

• Provide expertise on routine and non-routine testing in QC labs for bulk drug substances and drug products.
• Perform technical reviews, trend analysis, and investigations of atypical results.
• Assist with risk assessments, qualification, and validation activities for new equipment.
• Lead or participate in cross-functional teams on complex QC compliance deliverables.
• Support audits and inspections and ensure documentation to cGMP/cGDP standards.

Skills

GMP experience

Quality systems

Analytical testing

LIMS, Veeva, Go Track

Education

Bachelor's degree in Biology or Life Sciences

Tools

LIMS

Veeva

Go Track

Job description

Mon-Fri, 9 AM-5 PM

Job Description:

Job Duties:

• Provide expertise on routine and non-routine testing performed in QC laboratories of bulk drug substance and drug product in a multi-product facility.
• Responsible for technical review, interpretation, trending, quality review and investigation of atypical results.
• Assist with quality risk assessments, onboarding, qualification and implementation of non-routine, new equipment validation activities.
• Assist with implementing novel improvements and new ways of thinking toward lab processes and compliance activities.
• Assist and/or lead cross functional project team(s) responsible for complex QC related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS and CAPAs and change controls).
• Provide support during audits and inspections.
• Work independently with adequate training and background of fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, Osmolalilty, Microbiology and more.
• Review of analytical results within timeline right the first time.
• Documents work according to cGMP and cGDP.
• Adheres to established regulations and follows cGMP established by site.
• Reports abnormalities and deviations in a timely and accurate manner.
• Adheres to safety standards and identifies unsafe situations / habits and escalates appropriately.
• Maintains own training within compliance and assist other technicians and associates on operations upon completion of trainer qualification.
• Represents QC operations on cross-functional root cause analysis teams for deviations, CAPAs and risk assessments

Skills:

• 3-5 years of industry experience GMP experience is highly preferred Demonstrates strong interpersonal and communication skills (both written and oral) Strong customer focus, and an ability to interact with various departments and levels.
• Demonstrates ability to work independently and as part of a team, to meet departmental/facility goals Able to work across functions to achieve common goals.
• Demonstrates strong attention to detail, and an ability to focus on details of execution.
• System familiarity that would be helpful: LIMS, Veeva & Go Track

Education:

Bachelors' degree in Biology or Life Sciences required.