QC Associate II

About the role

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.

Responsibilities

• Assist with quality risk assessments, onboarding, qualification, and implementation of non-routine and new equipment validation activities.
• Implement novel improvements and new approaches to lab processes and compliance activities.
• Assist and/or lead cross-functional project teams responsible for complex QC-related compliance deliverables throughout the entire Quality System (deviations, investigations, OOS, CAPAs, and change controls).
• Provide support during audits and inspections.
• Work independently with a strong background in fundamental operations such as biochemistry, drug product device testing, UV-vis absorbance, gel electrophoresis, osmolality, and microbiology.
• Review analytical results accurately and within timelines.
• Document work according to cGMP and cGDP.
• Adhere to established regulations and follow cGMP standards set by the site.
• Report abnormalities and deviations in a timely and accurate manner.
• Adhere to safety standards, identify unsafe situations/habits, and escalate appropriately.
• Maintain personal training compliance and assist other technicians and associates upon completion of trainer qualification.
• Represent QC operations on cross-functional root cause analysis teams for deviations, CAPAs, and risk assessments.

Requirements

• 3-5 years of industry experience.
• GMP experience is highly preferred.
• Bachelor’s degree in Biology or Life Sciences required.

Skills

• Strong interpersonal and communication skills (both written and oral).
• Strong customer focus and ability to interact with various departments and levels.
• Ability to work independently and as part of a team to meet departmental and facility goals.
• Ability to work across functions to achieve common goals.
• Strong attention to detail and ability to focus on execution details.