QC Analyst II
2 months ago
6 Month Contract
Lexington, MA
PR: $40-52/hour
Job Summary
Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC technical protocols. May assist in sampling activities. This position is expected to maintain operational and GMP readiness of the QC areas as well as maintain critical reagent inventory such as antibodies and cell banks at business appropriate quantities. In addition, the individual may participate in more complex projects, operational excellence initiatives, and various quality systems with general supervision.
Job Responsibilities
- Specific Biochemistry Focus Areas:
- Product Testing: Area focuses on techniques such as SDS-PAGE Silver, QPCR, Potency, Kinetics assay, Enzyme Activity, pH, Osmo, A280 etc., in order to support in-process, release and stability testing.
- Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.
- Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.
- 40-50% Testing execution, participate in training analysts, trouble shooting of methods
- 20-30%: QC operations support which entails data review, data trending, OE/5S/LEAN initiatives, maintenance of equipment and reagents, lab house keeping, support for other QC groups. Compliance and quality systems (SOP revisions, input to quality systems records)
- 10-20% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Education & Qualifications
- Typically requires a bachelor’s degree and a minimum of 5+ years of related experience. (science related degree is preferred)
- Excellent communication, interpersonal and organizational skills.
- Ability to work well both independently and in a team environment.
- Ability to prioritize work and multitask.
- Previous experience in a GMP QC role is preferred
- Key Skills, Abilities, and Competencies
- Describe critical skill and abilities needed to successfully perform the job, which should be representative of the knowledge, skills, and abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Complete understanding and application principles, concepts, practices and standards. Full knowledge of industry practices. Position requires critical thinking.
- Key Skills: MS Office, LIMS, SAP, Trackwise , compliance and strong science understanding
- Limited to no travel expected. Travel between sites is required.
- The following physical abilities are required in order to fulfill the job duties:
- Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
- Ability to work around chemicals (if working around the laboratories)
- Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
- Ability to walk and stand for periods of time
- Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours
-
QC IT Application Analyst
3 months ago
Lexington, United States Sunrise Systems Full timeJob Description: The QC IT Application Analyst collaborates with the business and IT teams to provide project support for MA Biologics Operations Site Functions – Quality, Validation and Product Development. The QC IT Application Analyst manages their work with limited oversight- The scope of work includes, but is not limited to the following: ...
-
QC IT Application Analyst
3 weeks ago
Lexington, United States LanceSoft Full timeShift: 8AM to 5PM Onsite Expectations: For onboarding and training for the first few weeks should plan to be onsite 4-5 days a week. After onboarding and started working on projects, it is a minimum 3 days a week onsite, there will be times to be on site 4-5 days as needed. Job Description: The QC IT Application Analyst collaborates with the business...
-
QC Analyst II – Biochemistry
3 weeks ago
Lexington, United States The Fountain Group Full timePay: 48.00-58.00/hr.Length of Assignment: 6 months to start with potential for extension. qPCR experience required.Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug...
-
QC Analyst
4 weeks ago
Lexington, United States Synectics Inc Full timeJob DescriptionJob DescriptionDescription:Daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies using approved test methods or test methods derived from QC...
-
Randstad Life Sciences US | QC Analyst II
3 weeks ago
lexington, United States Randstad Life Sciences US Full time6 Month ContractLexington, MAPR: $40-53/hourJob SummaryPrimary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies...
-
Randstad Life Sciences US | QC Analyst II
3 weeks ago
lexington, United States Randstad Life Sciences US Full time6 Month ContractLexington, MAPR: $40-53/hourJob SummaryPrimary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug product manufacturing, stability and various protocol studies...
-
QC IT Application Analyst
3 weeks ago
Lexington, United States USDM Full timeAbout USDM USDM Life Sciences is a premier consulting company with 20+ years of experience assisting heavily regulated biotech, medical device, and pharmaceutical companies with their GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes are what sets us apart. From strategy to...
-
lexington, United States The Fountain Group Full timePay: 48.00-58.00/hr.Length of Assignment: 6 months to start with potential for extension. qPCR experience required.Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies. Testing may include but not limited to samples from drug substance and drug...
-
Quality Assurance Specialist
3 weeks ago
Lexington, Kentucky, United States Randstad Life Sciences US Full timeJob SummaryWe are seeking a highly skilled QC Analyst II to join our team at Randstad Life Sciences US. In this role, you will be responsible for the daily lab operations and execution of testing to support manufacturing operations/validation/or development studies.The primary duties of this position will focus on techniques such as SDS-PAGE Silver, QPCR,...
-
Quality Control Analyst
3 weeks ago
Lexington, United States LanceSoft, Inc. Full timeqPCR experience is required.Job Summary/Operations Involvement:Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol...
-
Quality Control Analyst
3 weeks ago
Lexington, United States LanceSoft, Inc. Full timeqPCR experience is required.Job Summary/Operations Involvement:Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol...
-
QC Manager/Sr. Manager
1 month ago
Lexington, United States Genezen Full timeThe field of gene therapy is growing rapidly and Genezen is here to meet the exacting needs of our clients. We provide process development, produce GMP viral vectors, and provide cell transduction for gene and cell therapy clinical trials and are proud to be a part of the process that leads to new cures. WORKING AT GENEZEN Many people have worked in...
-
lexington, United States LanceSoft, Inc. Full timeqPCR experience is required.Job Summary/Operations Involvement:Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol...
-
lexington, United States LanceSoft, Inc. Full timeqPCR experience is required.Job Summary/Operations Involvement:Primary Duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations /validation/or development studies.Testing may include but not limited to samples from drug substances and drug product manufacturing, stability and various protocol...
-
Quality Control Manager
1 month ago
lexington, United States TalentCraft Full timeJob Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...
-
Quality Control Manager
2 months ago
Lexington, United States TalentCraft Full timeJob Title: Quality Control Bioassay and Virology Operations LeadPosition Summary:This role is responsible for the daily management and operations of the QC Bioassay and Virology Testing team within the QC Operations department, supporting clinical and commercial AAV-based products. Key responsibilities include overseeing cGMP processes such as in-process,...
-
Information Security Analyst
4 weeks ago
Lexington Park, United States Imagine One Technology & Management Ltd Full timeJob DescriptionJob DescriptionImagine One Technology & Management is currently seeking an Information Security Analyst “contingent” on award of the associated work to the Imagine One Team. This position supports the U.S. Navy in Lexington Park, Maryland.The Information Security Analyst will plan, implement, upgrade, or monitor security measures for...
-
Technical IT Systems Analyst with GxP Experience
3 weeks ago
Lexington, Kentucky, United States USDM Full timeAbout USDM Life SciencesUSDM Life Sciences is a leading consulting company with over two decades of experience helping heavily regulated biotech, medical device, and pharmaceutical companies implement GxP technologies to accelerate growth. Our deep domain knowledge and technology expertise in life sciences business processes set us apart.We have delivered...
-
Security Analyst
3 weeks ago
Lexington, United States MIT Lincoln Laboratory Full timeSelect how often (in days) to receive an alert: JOIN OUR TALENT NETWORKSecurity Analyst Apply nowDate: Nov 5, 2024 Location: Lexington, MA, US Company: MIT Lincoln Laboratory Position Description The Security Analyst II is a member of the Threat Assessment Team - which performs analysis on cyberthreats, research and develop new methods for detecting...
-
Security Analyst
6 days ago
Lexington, United States MIT Lincoln Laboratory Full timeSelect how often (in days) to receive an alert: JOIN OUR TALENT NETWORKSecurity Analyst Apply nowDate: Dec 4, 2024 Location: Lexington, MA, US Company: MIT Lincoln Laboratory Position Description The Security Analyst II is a member of the Threat Assessment Team - which performs analysis on cyberthreats, research and develop new methods for detecting...