Job 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
Location: Plainville MA 02762
Duration: 6 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday To Friday From 08:00 AM To 04:30 PM
Summary
Our client is seeking a Quality Control Bioanalytical Scientist to join thier Quality Control Bioanalytical Laboratory team supporting cGMP clinical and commercial manufacturing. This position is responsible for performing routine and complex bioanalytical testing, troubleshooting laboratory methods and equipment, reviewing data and documentation, supporting method transfers and validations, and maintaining compliance with cGMP and applicable regulatory requirements. The ideal candidate has hands-on QC laboratory experience, strong bioanalytical testing skills, and the ability to work effectively in a fast-paced manufacturing environment.
Responsibilities
- Perform timely, Right First Time (RFT) cGMP QC testing and documentation for in-process, release, stability, STAT, and critical utility samples.
- Perform and troubleshoot routine and complex bioanalytical assays and laboratory testing, including TOC/Conductivity, pH, osmolality, FTIR, A260, cell count/viability, ddPCR/qPCR, VGT, TCID50, icIEF, CE-SDS, SDS-PAGE, ELISA, UHPLC, and other applicable assays.
- Support method transfer, qualification, validation, verification, and troubleshooting activities for QC methods.
- Support compendial method verification and serve as a technical resource as assigned.
- Perform and support laboratory equipment maintenance, calibration, troubleshooting, and new equipment implementation.
- Review laboratory data and documentation to ensure accuracy, data integrity, and cGMP compliance.
- Perform routine laboratory operations, including reagent preparation, material stocking, laboratory cleaning and organization, and logbook completion and review.
- Support reference standard and critical reagent programs, including inventory management and trending.
- Author and revise SOPs, Work Instructions, Forms, and other technical documents.
- Prepare and manage quality records, including deviations, OOS, CAPAs, LIRs, and related documentation.
- Support laboratory inspection readiness and participate in audits and inspections as needed.
- Maintain required training and provide training to other team members when assigned.
- Utilize laboratory and quality systems, including Empower, SampleManager LIMS, TrackWise, D2, Microsoft Office, Smartsheet, and other applicable systems.
- Participate in continuous improvement initiatives and cross-functional projects.
- Identify and troubleshoot technical or laboratory issues and communicate solutions effectively.
- Collaborate with QC, manufacturing, facilities, maintenance, automation, and other cross-functional teams.
- Follow cGMP, laboratory safety, quality, and regulatory requirements at all times.
Required Skills
- Bachelor's degree in Biology, Molecular Biology, Analytical Chemistry, or a related scientific discipline.
- 1 to 3+ years of relevant industry or laboratory experience is required.
- Prior QC experience in a manufacturing environment is very highly desired.
- Hands-on experience performing laboratory testing and troubleshooting, preferably within a GxP/cGMP-regulated Quality Control laboratory.
- Experience with routine and complex bioanalytical methods and laboratory instrumentation.
- Experience with method transfer, verification, validation, or qualification activities.
- Knowledge of cGMP practices, QC laboratory operations, quality systems, data integrity, and inspection readiness.
- Experience preparing technical documentation such as SOPs, Work Instructions, Forms, and quality records.
- Strong analytical, troubleshooting, and problem-solving skills.
- Strong written and verbal communication and interpersonal skills.
- Ability to work independently with minimal to moderate supervision while managing multiple priorities.
- Strong attention to detail, organization, accountability, and adaptability.
- Proficiency in English, both written and verbal.
Work Environment & Schedule
- Occasional off-shift, weekend, and holiday hours may be required to support manufacturing operations.
- Position requires daily laboratory and computer work and the use of appropriate laboratory PPE.
- Work may involve exposure to biohazardous/infectious materials, chemicals, dry ice, and strong odors.
- Ability to lift up to 30 lbs, with or without reasonable accommodation.
- Position may be designated as essential personnel and may require work during inclement weather or emergency situations.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
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/ |
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.Skills
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