Molecular Assay Production & QC Specialist

Asuragen, Inc.; Austin (TX); Vor Ort; USD 50.000 - 82.000; Vollzeit

Zusammenfassung

Bio-Techne in Texas is seeking an Advanced Research Associate to support end-to-end production with focus on formulation and quality control of reagents, ensuring compliance with cGMP/GLP/ ISO standards. Responsibilities include following manufacturing protocols, testing products, documenting non-conformances, maintaining inventory, and assisting in equipment maintenance and validation.

Qualifications include a Bachelor's degree in a scientific discipline and 2–5+ years in production; experience

Qualifikationen

• Bachelor’s degree in a scientific discipline and 2–5+ years in production.
• Experience in molecular assays, PCR/CE, qPCR or NGS preferred.
• Familiarity with cGMP, GLP, ISO or other regulated environments.
• Proficient in MS Office and database management.
• Strong data recording and documentation skills.
• Ability to work in a fast-paced manufacturing setting.

Aufgaben

• Follow manufacturing protocols to formulate reagents.
• Functionally test products, reviewing data obtained for compliance to established specifications.
• Assist in downstream production by following work instructions to fill, label and package reagents.
• Maintains quality of manufactured products; recording information accurately while following Good Documentation Practices as well as verifying work performed by co-workers.
• Document non-conformances and deviations.
• Follows work instructions to inspect, test and release raw materials.
• Perform rework as required according to designated work instructions.
• Coordinate and perform equipment maintenance.
• Perform equipment validation as required.
• Perform product stability testing according to work instructions.
• Maintain accurate inventory through the timely and accurate completion of work order and inventory transactions and by performing weekly cycle counts.
• Perform general lab maintenance, cleaning, and organization.
• Execute work in a safe manner.
• Notifying management of any safety issues or risks and assisting in remediation of those safety issues or risks.
• Apply experience and logic to resolve a variety of moderately complex problems.
• Provide support for cross-functional teams on complex projects.
• Identify and implement process improvements.
• Revise and update procedures as needed.
• Perform all other duties as assigned.

Kenntnisse

Molecular assays

PCR/CE

qPCR

NGS

Lean manufacturing

cGMP/GLP/ISO

ERP systems

Teamwork

Ausbildung

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Database management

Jobbeschreibung

Bio-Techne in Texas is seeking an Advanced Research Associate to support end-to-end production with focus on formulation and quality control of reagents, ensuring compliance with cGMP/GLP/ ISO standards. Responsibilities include following manufacturing protocols, testing products, documenting non-conformances, maintaining inventory, and assisting in equipment maintenance and validation.

Qualifications include a Bachelor's degree in a scientific discipline and 2–5+ years in production; experience