Quality Control (Senior Level)
Westborough, MA 01581 US
The QC Analyst will be responsible for laboratory-based execution of quantitative, semi-quantitative, and qualitative test methods in support of the Company’s portfolio of hollow fiber products for bio-pharmaceutical manufacturing. This role will also support method validation, report preparation, instrument maintenance and other activities in Test laboratory.
To maintain accurate and inspectable paper and electronic records To establish and maintain good working relationships with all internal customers To lead or assist in non-routine analysis, report-writing and dossier amendments as required Plan the development and validation of new equipment or procedures Ensure QC inspection and analysis is carried out using compliant equipment to validated methods by appropriately trained staff Develop and maintain specialized technical expertise in order to provide support for existing products and ongoing GxP operations as required Drive LEAN implementation as required Comply with EHS regulations & policies.
What you’ll do
§ With minimal guidance perform routine testing and data review of raw material and batch release samples in an ISO 9001 and ISO 13485 environment.
§ Contribute to critical validation activities on newly developed test methods.
§ Accountable for the on-time delivery of high-quality data in support of in-process, release, and stability activities.
§ Perform routine assays such as Gel Permeation Chromatography (GPC), Porometry, viscosity, Karl Fischer titration and others analytical methods.
§ Under guidance perform broad range of troubleshooting techniques.
§ After training may write and revise SOPs and Work Instructions for review and approval.
§ Accountable for the on-time delivery of high-quality data in support of in-process and release activities.
§ Train on additional methodologies and provide support to a broader spectrum of testing responsibilities.
§ Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible
§ Support investigations through data gathering or interview process.
§ Contribute to maintenance and troubleshooting of laboratory instrumentation.
Who you are
§ Minimum a high school degree with 8+ years of experience in a QC environment, or an A.S. with 4+ years of experience in a QC environment, desired a B.S with 2+ years of experience in a QC environment.
§ Experience in analytical test methods and instrumentation such as GPC, viscometry, and/or Karl Fischer moisture analysis is highly preferred.
§ Knowledge of lab software applications (e.g., OpenLabs, LabX, LIMS, ELN, LES, SDMS) desired.
§ High attention to detail with strong general laboratory and good organizational skills.
§ Ability to work independently as well as part of a team, to complete assignments within defined time constraints.
§ Ability or willingness to learn to interpret and apply governing quality system requirements and industry best practices.
§ Ability to work under pressure.
§ Demonstrates problem solving and analytical thinking skills.
§ Clear written and verbal communication skills.
§ Computer literacy and the ability to use Microsoft Office software
§ Problem Sensitivity: The ability to tell when something is wrong or is likely to go wrong
§ A can-do attitude