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: Laboratory Quality Specialist
Location: Waltham MA - 02453
Duration: 3 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Waltham MA - 02453
Duration: 3 Months
Job Type: Temporary Assignment
Work Type: Onsite
Shift: Monday To Friday from 09:00 AM To 05:00 PM
Summary
The Lab Quality Specialist II will support the management, maintenance, and continuous improvement of laboratory Quality Management Systems (QMS). This role focuses on ensuring quality compliance, maintaining accurate documentation, supporting audit readiness, and driving continuous improvement initiatives. The specialist will collaborate with cross-functional teams and internal and external stakeholders to maintain quality standards and ensure compliance with applicable regulatory requirements.
Responsibilities
- Manage, organize, maintain, and control quality documentation within the Quality Management System (QMS).
- Support successful completion of internal and external audits, ensuring audit readiness and compliance.
- Collaborate with cross-functional teams to develop, review, update, and implement quality instructions, procedures, and guidelines.
- Support continuous improvement initiatives, including Corrective and Preventive Actions (CAPA), Change Control (CC), non-conformance management, and risk assessments.
- Review and approve customer projects to ensure quality requirements are met before delivery.
- Support qualification, maintenance, and control of laboratory instruments and equipment.
- Work closely with internal departments and external customers to address quality-related requirements.
- Identify opportunities for process improvements and contribute to maintaining an effective and compliant quality system.
Required Skills
- Bachelor's degree in Life Sciences, Biology, Biotechnology, or a related scientific discipline.
- Minimum 1 year of experience in a quality assurance, contract laboratory, or quality control (QC) laboratory environment.
- Experience working with a Quality Management System aligned with GCP, ISO 17025, or equivalent quality standards.
- Knowledge of CAPA, change control, non-conformance management, and risk management.
- Experience with quality documentation, document control, and audit support.
- Experience with Laboratory Information Management Systems (LIMS) and document management systems.
- Proficiency in Microsoft Office applications.
- Strong analytical and problem-solving abilities.
- Excellent written and verbal communication skills.
- Strong interpersonal and cross-functional collaboration skills.
- Excellent organizational skills and attention to detail.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Waltham, MA |
| Industry | Computer/IT Services |
| Salary | $30–$38 |
| 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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