Opis Senior Services Group
QC Analyst
Opis Senior Services Group, Westborough, Massachusetts, us, 01581
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 report preparation, instrument maintenance, and other activities in the QC laboratory.Responsibilities:
Support QC testing laboratory operations and quality records in line with GLP.Contribute to critical validation activities on newly developed test methods.With minimal supervision, perform routine sample analysis as per instrument and test specific standard operating procedures (SOP).Contribute to preparation of standard operating procedures for tests and instrumentation.With minimal supervision, prepare qualification and validation protocols and reports for test procedures and instrumentation.Contribute to maintenance and troubleshooting of laboratory instrumentation.Accountable for the on-time delivery of high-quality data in support of in-process, release, and stability activities.Ensure data integrity and GMP compliance requirements are followed within the laboratories.Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible.Qualifications:
Minimum a high school degree with 10+ years of experience, or an A.S. with 5+ years of experience, desired a B.S with 3+ years of experience or M.S. with 1+ years of experience.Experience in testing laboratory in manufacturing environment, QC experience preferred.Hands-on experience with analytical techniques used in polymer analysis (instrument operation, testing, troubleshooting, etc.).Hands-on experience performing routine sample analysis and method validation preferred.Understanding of scientific principles and techniques used in QC laboratories desired.Familiarity with analytical techniques like viscosity, moisture, chromatography, etc.Experience of working within an ISO 9001, 13485 and/or cGMP (GLP) QMS environment is preferred.Demonstrated ability to solve problems, develop plans and advance to completion on time and in full.Diverse technical understanding and ability to apply skills/knowledge to new technology.Ability to identify and report any quality or compliance concerns and take immediate corrective action as required.
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Support QC testing laboratory operations and quality records in line with GLP.Contribute to critical validation activities on newly developed test methods.With minimal supervision, perform routine sample analysis as per instrument and test specific standard operating procedures (SOP).Contribute to preparation of standard operating procedures for tests and instrumentation.With minimal supervision, prepare qualification and validation protocols and reports for test procedures and instrumentation.Contribute to maintenance and troubleshooting of laboratory instrumentation.Accountable for the on-time delivery of high-quality data in support of in-process, release, and stability activities.Ensure data integrity and GMP compliance requirements are followed within the laboratories.Participate in continuous improvement activities by identifying and appropriately escalating process and product quality gaps, providing solutions when possible.Qualifications:
Minimum a high school degree with 10+ years of experience, or an A.S. with 5+ years of experience, desired a B.S with 3+ years of experience or M.S. with 1+ years of experience.Experience in testing laboratory in manufacturing environment, QC experience preferred.Hands-on experience with analytical techniques used in polymer analysis (instrument operation, testing, troubleshooting, etc.).Hands-on experience performing routine sample analysis and method validation preferred.Understanding of scientific principles and techniques used in QC laboratories desired.Familiarity with analytical techniques like viscosity, moisture, chromatography, etc.Experience of working within an ISO 9001, 13485 and/or cGMP (GLP) QMS environment is preferred.Demonstrated ability to solve problems, develop plans and advance to completion on time and in full.Diverse technical understanding and ability to apply skills/knowledge to new technology.Ability to identify and report any quality or compliance concerns and take immediate corrective action as required.
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