QC Associate II

Requirement/Must Have:

• Bachelor s degree in Biology, Life Sciences, or related field required.
• 3 to 5 years of industry experience.
• GMP experience preferred.
• Hands-on experience with HPLC testing and laboratory analytical techniques.
• Strong understanding of cGMP and cGDP requirements.
• Strong attention to detail and documentation accuracy.
• Ability to work independently and collaboratively in team environments.
• Strong written and verbal communication skills.

Experience:

• Experience performing in-process testing in pharmaceutical, biotechnology, or laboratory environments.
• Experience with HPLC titer testing preferred.
• Experience with aseptic techniques preferred.
• Experience with osmolality, total organic carbon (TOC), conductivity, pH, UV-Vis absorbance, and endotoxin testing preferred.
• Experience handling sample aliquotation and laboratory support activities.
• Experience maintaining laboratory inventory and managing reagents and consumables.
• Experience identifying and reporting deviations, abnormalities, and out-of-specification results.
• Experience following safety, quality, and compliance procedures in regulated environments.

Responsibilities:

• Execute routine and non-routine testing of bulk drug substances and intermediates.
• Perform laboratory testing including HPLC titer, UV-Vis absorbance, endotoxin testing, pH, osmolality, TOC, conductivity, and sample aliquotation.
• Perform laboratory operations independently following appropriate training.
• Maintain inventory of laboratory consumables and materials.
• Dispose of expired reagents and materials according to procedures.
• Identify and report equipment or process anomalies.
• Deliver accurate analytical results within established timelines.
• Document all laboratory activities in compliance with cGMP and cGDP standards.
• Adhere to all site procedures, regulatory standards, and quality systems.
• Report deviations, abnormal findings, and out-of-specification results promptly.
• Maintain laboratory cleanliness and organization according to 5S standards.
• Follow all laboratory safety procedures and escalate unsafe conditions when identified.
• Ensure training requirements remain current and compliant.

Should Have:

• Strong analytical and problem-solving skills.
• Strong customer-service orientation.
• Ability to work across departments and functions collaboratively.
• Ability to focus on execution details and maintain high-quality standards.
• Strong organizational and multitasking skills.
• Commitment to safety, compliance, and operational excellence.

Skills:

• HPLC.
• UV-Vis Spectroscopy.
• Endotoxin Testing.
• Aseptic Technique.
• Osmolality Testing.
• TOC Analysis.
• Conductivity Testing.
• pH Testing.
• cGMP.
• cGDP.
• Laboratory Documentation.
• Quality Control.
• Sample Aliquotation.
• Pharmaceutical Testing.
• Analytical Testing.