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: Manufacturing Associate
Location: Plainville MA 02762
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Location: Plainville MA 02762
Duration: 12 Months
Job Type: Temporary Assignment
Work Type: Onsite
Summary
Execute manufacturing work instructions and complete assigned tasks while spending approximately 90% of working time in manufacturing suites. Work in a dynamic GMP/cGMP environment with moderate complexity and limited supervision, maintaining high standards of safety, quality, documentation, and cleanroom compliance. A high school diploma or equivalent is required, along with a minimum of one year of experience in manufacturing, operations, production, laboratory, or a related field. Experience in a cGMP environment is preferred.
Responsibilities
- Execute work instructions and apply job skills to complete assignments.
- Achieve full training status and assist in training staff.
- Perform semi-routine assignments and receive instruction on new processes.
- Maintain accurate inventory and batch records.
- Inspect finished products for adherence to specifications.
- Assist with batch record reconciliation.
- Assist with preventative maintenance tasks.
- Adhere to Quality Management Systems (QMS).
- Assist with Nonconformance/CAPA closures.
- Identify and communicate items requiring escalation.
- Maintain a clean and safe work environment.
- Follow company policies related to safety, training, GDP, GMP, and cleanroom gowning.
- Spend approximately 90% of working time in manufacturing suites.
- Perform manufacturing activities safely to prevent product releases, accidents, and injuries.
- Use computer systems and manufacturing software daily.
- Follow GMP requirements, including closed-toe footwear and restrictions on piercings and nail polish.
Required Skills
- Technical expertise in biopharmaceutical manufacturing equipment, principles, and processes.
- Strong understanding of current GMP and safety standards.
- Ability to function effectively in a dynamic environment and balance multiple priorities.
- Ability to learn and use new software and tools.
- Ability to make decisions involving moderately complex GMP manufacturing activities with minimal to moderate supervision.
- Ability to recognize situations requiring further evaluation and report them to senior operators or management.
- Effective written and verbal communication skills with peers, senior associates, and area management.
- Understanding of operational documents and GMP requirements for accuracy and completeness.
- Ability to safely perform activities to prevent product releases, accidents, and injuries.
- Ability to perform aseptic and/or sterile gowning as required.
- Ability to read, write, and review documentation for extended periods.
- Ability to use PPE and comply with cleanroom requirements.
- Ability to work with or around dry ice, liquid nitrogen/cryogenic materials, hazardous agents, infectious agents, and significant temperature changes.
- Ability to meet physical requirements, including prolonged sitting and standing, walking, lifting, reaching, handling materials, stooping, kneeling, and crouching.
- Ability to meet visual requirements, including close, distance, color, peripheral, and depth perception and the ability to adjust focus.
- Ability to talk and hear effectively during work activities.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Numbers & Facts
| Location | Plainville, MA |
| Industry | Computer/IT Services |
| Salary | $27–$28 |
| 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
- Asepsisunmatched
- Biotech and Pharmaceuticalunmatched
- Cleanroomunmatched
- Communication Skillsunmatched
- Computer Systemsunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Current Good Manufacturing Practice (cGMP)unmatched
- Depth Perceptionunmatched
- Documentationunmatched
- Documentation Reviewunmatched
- GMP (Good Manufacturing Practices)unmatched
- Hazardous Materials/Substancesunmatched
- Healthcareunmatched
- High School Diplomaunmatched
- Inventory Managementunmatched
- Inventory Reportsunmatched
- Laboratory Equipmentunmatched
- Manufacturingunmatched
- Manufacturing Equipmentunmatched
- Manufacturing Operationsunmatched
- Manufacturing Softwareunmatched
- Manufacturing Systemsunmatched
- Multitaskingunmatched
- Pathogensunmatched
- Physical Demandsunmatched
- Presentation/Verbal Skillsunmatched
- Preventative Maintenanceunmatched
- Product Developmentunmatched
- Purchasing/Procurementunmatched
- Quality Managementunmatched
- Reconciliationunmatched
- Safety Standardsunmatched
- Safety Trainingunmatched
- Safety/Work Safetyunmatched
- Scientific Researchunmatched
- Staff Trainingunmatched
- Technical Deliveryunmatched
- Workforce Managementunmatched
- Writing Skillsunmatched
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