Highlights
This position within the Quality Control Bioanalytical laboratory team supports cGMP-compliant clinical and commercial manufacturing by performing routine and complex bioanalytical testing, troubleshooting, laboratory operations, equipment maintenance, data and documentation review, training, quality records management, method transfer support, and continuous improvement activities. Perform and troubleshoot TOC/Conductivity, compendial assays, FTIR, A260, cell count and viability, Viral Genome Titer (VGT) by ddPCR/qPCR, infectivity assays, icIEF/CE-SDS, SDS-PAGE gels, ELISA, UHPLC, and other laboratory assays as assigned.
Numbers & Facts
| Location | Plainville, MA |
| Industry | Computer/IT Services |
| Salary | $25–$30 |
| Company Size | 100 to 499 employees |
| Year Founded | 2009 |
| Website | http://www.tekwissen.com/ |
Description
Overview:
TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to clients worldwide. The job opportunity below is with one of our clients specializing in biotechnology product development services. The client is dedicated to supplying laboratory equipment, chemicals, supplies, and services essential in healthcare, scientific research, safety, and education. As a global leader in serving the scientific community, the organization generates approximately $40 billion in annual revenue and is committed to making the world healthier, cleaner, and safer. Their global team delivers innovative technologies, convenient procurement solutions, and pharmaceutical services through industry-leading brands.
Position: Quality Control Scientist
Location: Plainville, MA 02762
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday - Friday 8:00 AM-4:30 PM (occasional off-shift hours, weekends, and holidays may be required as needed to support manufacturing operations).
Summary:
This position within the Quality Control Bioanalytical laboratory team supports cGMP-compliant clinical and commercial manufacturing by performing routine and complex bioanalytical testing, troubleshooting, laboratory operations, equipment maintenance, data and documentation review, training, quality records management, method transfer support, and continuous improvement activities. The role directly supports the quality, safety, and regulatory compliance of products released to market.
Responsibilities:
- Perform cGMP QC bioanalytical testing, troubleshooting, laboratory operations, equipment maintenance, data review, training, quality records management, and method transfer support.
- Execute Right First Time (RFT) testing and documentation for in-process, release, stability, and critical utility (TOC/C) testing following approved procedures and safe laboratory practices.
- Troubleshoot routine technical issues and laboratory problems.
- Perform and troubleshoot TOC/Conductivity, compendial assays, FTIR, A260, cell count and viability, Viral Genome Titer (VGT) by ddPCR/qPCR, infectivity assays, icIEF/CE-SDS, SDS-PAGE gels, ELISA, UHPLC, and other laboratory assays as assigned.
- Support method transfer, qualification, validation, verification, and troubleshooting activities for QC methods.
- Serve as technical lead for compendial verifications.
- Perform and support QC equipment maintenance, calibration, and onboarding activities in coordination with Facilities, Maintenance, Automation, and vendors.
- Conduct data and documentation review to ensure data integrity and compliance.
- Perform routine laboratory operations, including cleaning, organization, stocking materials, reagent preparation, and completion and review of logbooks.
- Support reference standards and critical reagents programs, including inventory management and trending.
- Complete required cGMP and job-specific training on time.
- Train team members and develop On-the-Job Training (OJT) materials as assigned.
- Author and revise SOPs, Work Instructions, Forms, and other technical documents.
- Author and manage quality records, including LIRs, Deviations, OOS investigations, and CAPAs.
- Support laboratory inspection readiness and participate in audits and inspections.
- Utilize laboratory software and quality systems such as Empower, SampleManager LIMS, TrackWise, D2, Microsoft Office applications, Teams, PowerPoint, and Smartsheet.
- Participate in continuous improvement initiatives and team meetings.
- Collaborate effectively with cross-functional teams and communicate timely solutions to routine and complex issues.
- Apply scientific judgment and working knowledge of cGMP Quality Control systems and applicable regulatory requirements.
- Safely handle biohazardous or infectious materials, dry ice, chemicals, and strong odors.
- Support business operations during emergency situations, including potential off-shift, weekend, holiday, or extended-hour coverage as required.
- Perform additional duties as assigned.
Required Skills:
- Bachelor's degree in Biological Science, Molecular Biology, Analytical Chemistry, or a related scientific discipline.
- A minimum of 1 3+ years of relevant industry experience is required.
- Experience as a laboratory analyst or scientist performing testing and troubleshooting, preferably in a GxP-regulated Quality Control laboratory.
- Experience with routine and complex bioanalytical methods and instrumentation.
- Experience with method transfers, qualification and validation support, and technical document authoring.
- Working knowledge of QC laboratory safety practices, scientific processes, and cGMP requirements.
- Experience supporting quality systems, inspection readiness, audits, and regulatory compliance activities.
- Strong troubleshooting and problem-solving skills.
- Ability to work safely and effectively in a fast-paced, dynamic laboratory environment.
- Ability to manage multiple priorities, meet deadlines, and maintain strong attention to detail.
- Effective verbal and written communication, active listening, interpersonal, and collaboration skills.
- Ability to read, write, and speak English.
- Demonstrated accountability, adaptability, and proactive work habits.
- Ability to work semi-independently with minimal to moderate supervision while maintaining alignment with supervisors and managers.
- Ability to perform daily laboratory and computer work, including use of laboratory PPE, frequent hand use, sitting, standing, bending, climbing, pushing, reaching, writing, talking, and hearing.
- Ability to lift up to 30 lbs with or without reasonable accommodation.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
About Company
WE THE TEKWISSEN PEOPLE
TekWissen offers you a broader portfolio of services, industry-leading solutions, and the meaningful innovations that give you greater flexibility and speed to respond to market dynamics, reduced costs and risk to improve enterprise performance, and increased productivity to enable growth.
To keep pace with global market demands, TekWissen keeps its finger on the pulse of change. Our organized approach to guiding a project from its inception to closure. Managing projects is becoming more and more important as we enter the digital era. To cope with the pace that this transition demands, a method is required to manage projects so they can yield quality work, while incorporating efficient use of time and resources.
Project involves identifying which quality standards are relevant to the project and determining how to satisfy them.
It is important to perform quality planning during the Planning Process and should be done alongside the other project planning processes because changes in the quality will likely require changes in the other planning processes, or the desired product quality may require a detailed risk analysis of an identified problem. It is important to remember that quality should be planned, designed, then built in, not added on after the fact.
Capabilities and accomplishments in one TekWissen business enhance the opportunity for success in the others. Put simply, TekWissen's unique combination of attributes promotes success.