Careers

Job Description

The Quality Assurance Senior Technician is responsible for supporting the Quality Assurance team in testing manufactured antibody and protein products, and qualifying incoming critical reagents. This includes the ability to work collaboratively with multiple groups, perform tasks independently, interpret results and troubleshoot. Investigate quality related nonconformances associated with deviations, test failures and test results failing to meet acceptance standards.

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Key Responsibilities

• Perform all aspects of Quality Assurance assays following SOPs and ISO requirements and review analytical data for accuracy and quality
• Ensure test methods are validated or verified as appropriate to the method
• Work both independently and collaboratively as part of the Quality Assurance team
• Operate and monitor inspection equipment
• Calibrate laboratory equipment and notify QA Manager when equipment requires servicing
• Assure timely completion and review of testing documentation
• Perform testing of products throughout the manufacturing life cycle, including stability samples
• Record, review and analyze quality data
• Qualify and validate all assays transferred to QA
• Ensure the timely and successful resolution of investigations associated with deviations, test failures and test results failing to meet acceptance standards
• Perform routine analytical testing for R&D as assigned by QA Management
• Work collaboratively with R&D to ensure successful transfer of developed assays to QA and resolve any technical issues that arise during the transfer
• Order, review and maintain stocks of standards and other QA reagents as required
• Presentation and communication of data and project updates to management

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Requirements

• Bachelor’s degree in Biochemistry, Chemistry or other Life Science related field
• 4+ years of bioassay laboratory experience, specifically with ELISA assay qualification and testing
• Automated liquid handling experience
• Experience in assay development and validation for product analysis using multi-well plate formats
• Experience with various techniques and equipment associated with Western Blotting, SDS-PAGE, HPLC and spectroscopy
• Proficient in Microsoft Office, including Excel

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Preferred Requirements

• Experience in supporting stability programs for biotechnology or pharmaceutical products
• Experience with statistical software (JMP, SAS, Prism, etc.) for data trending
• Working knowledge of ISO 9001:2015 or 13485 standards and Quality Management Systems (QMS) and/or GMP/GLP regulations

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Position Summary

Leads development and improvements of production processes used to manufacture antibodies and conjugates. Transfers and validates production methods from R&D to manufacturing groups.

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Principal Duties and Responsibilities:

• Leads the development, improvement, qualification, and validation of antibody manufacturing methods. Integrates innovative purification technologies.
• Scale-up chromatographic processes of antibodies using multiple purification platforms (e.g. AKTA Pilot, Avant) and chromatography methods such as affinity, ion exchange and size exclusion.
• Develop scalable purification techniques including harvesting, filtration, tangential flow filtration and UF/DF.
• Collects and compiles data and records in laboratory notebooks. Maintains batch records and working templates for raw data and writes SOPs regularly. Writes documents to support tech transfer.
• Provides oversight and guidance to manufacturing team members during the development and execution of manufacturing validation and qualification plans, protocols, and reports.
• Participates in the qualification of critical reagent suppliers and reagents.
• Contributes to product and process risk management activities including design changes, complaint handling, and failure analyses.
• Gives status updates on assigned tasks and interprets and effectively communicates scientific findings/results.
• Attends industry related exhibits, conventions and trade shows.
• Provides scientific/technical expertise on product rejection/acceptance.

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Education and Experience Requirements:

• Master’s in Biotechnology, Bioprocessing, Bioscience or a related field plus 3-4 years of industry experience or PhD with 1-2 years of industry experience
• Experience in protein purification and conjugation techniques
• Ability to lead a project independently
• Experience in automated purification
• Working knowledge of quality system regulations and international standards such as ISO 9001/2105 and ISO 13485 preferred

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Physical Effort and Dexterity Requirements:

Mobility Factors: Sitting--90%, Walking--5%, Standing--5%

Visual Acuity, Hearing, and Speaking: Ability to perceive colors, clear speech, normal hearing, and vision.

Environmental Conditions: Normal fluctuations in heat and air conditioning, exposure to normal animal keeping conditions.

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Apply for this position here.