Manufacturing Quality Specialist
3 weeks ago
Job Summary:
The Manufacturing Quality Specialist is an individual contributor responsible for managing change control records and leading projects that support Manufacturing Operations. This role is vital in monitoring and reporting deviations, change controls, and improvement projects to ensure compliance and operational excellence in biopharmaceutical manufacturing.
Key Responsibilities:
- Own and manage change control records, CAPAs (Corrective and Preventive Actions), Periodic Review documents, and Standard Operating Procedure (SOP) revisions.
- Support the monitoring and reporting of deviations and change controls, ensuring timely resolution and compliance with regulatory requirements.
- Identify areas for continuous process improvement, applying operational excellence tools to reduce process variability and deliver measurable efficiency gains.
- Lead simple to moderate cross-functional projects, ensuring that project goals are met within the defined scope. Influence peers to achieve common objectives and maintain focus during project meetings.
- Write and maintain technical documents, including SOPs, protocols, and deviation reports, ensuring clarity and compliance with cGMP (current Good Manufacturing Practice) standards.
- Assist in the preparation for audits and inspections, ensuring all documentation and processes meet regulatory expectations.
Qualifications:
- Bachelor’s Degree with a focus in Biopharmaceuticals or a related field.
- Minimum of 2 years of experience in a cGMP environment within the biopharmaceutical or pharmaceutical manufacturing industry.
- Preferably experience as a manufacturing operator or technician.
- Knowledge of cGMP systems and regulations from various regional jurisdictions.
- Familiarity with change controls, deviations, project management, and audit/inspection processes.
-
Manufacturing Quality Specialist
2 weeks ago
Fremont, CA, United States Meet Full timeJob Summary:The Manufacturing Quality Specialist is an individual contributor responsible for managing change control records and leading projects that support Manufacturing Operations. This role is vital in monitoring and reporting deviations, change controls, and improvement projects to ensure compliance and operational excellence in biopharmaceutical...
-
Manufacturing Site Specialist
3 weeks ago
Fremont, United States Global Channel Management Full timeAbout the job Manufacturing Site Specialist Manufacturing Site Specialist needs 5 years business experience with significant experience in a sales/service function required, preferably at a customer location.Manufacturing Site Specialist requires:BS/BA, preferably chemical engineering, chemistry, related fields, or equivalent industry experience. Must have a...
-
Supplier Quality Engineer
3 days ago
Fremont, United States Quanta Manufacturing Fremont Full timeJob Summary:Provide expertise in Quality Assurance and process improvement tools and methods to targetedfunctions of the organization to support them in their continuous improvement activities. Contribute in the advancement of the organization in Quanta for business prosperity and customer satisfaction. Execute the initiatives of the organization in the...
-
Supplier Quality Engineer
3 weeks ago
Fremont, United States Quanta Manufacturing Fremont Full timeJob Summary:Provide expertise in Quality Assurance and process improvement tools and methods to targeted functions of the organization to support them in their continuous improvement activities. Contribute in the advancement of the organization in Quanta for business prosperity and customer satisfaction. Execute the initiatives of the organization in the...
-
Manufacturing Compliance Specialist
3 weeks ago
Fremont, United States Boehringer Ingelheim Full timeResponsibilities:Excellent employment opportunity for a MFG Compliance Specialist in the Fremont, CA area.Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations.Will support in the monitoring, reporting of deviations, change controls and improvement projects.Responsible to own and change...
-
Manufacturing Compliance Specialist
3 weeks ago
Fremont, United States Astrix Full timeOur client is a global, research-driven pharmaceutical focusing on treatment options for diseases and conditions for which there is no satisfactory treatment option to date. The company is looking for an MFG Compliance Specialist to join the team. This is an amazing opportunity to work on cutting edge treatments and make a difference!Location: Fremont,...
-
Manufacturing Quality Control Supervisor
4 weeks ago
Fremont, California, United States Hyve Solutions Full timeHyve Solutions is a leader in the data center solutions industry, designing, manufacturing, and delivering custom Server, Storage, and Networking Solutions to the world's largest Cloud, Social Media, and Enterprise companies.As a Manufacturing Quality Control Supervisor, you will be responsible for managing all aspects of the quality control production...
-
Manufacturing Compliance Specialist
2 weeks ago
Fremont, United States eTeam Full timeJob Title: Manufacturing Compliance Specialist Location: Fremont, CADuration: 6 MonthsPay-rate: $46.22/hr.Shift Timings: 1st shift / Monday-Friday, 08:00 AM - 05:00 PM Experience: 2 Years Experience with cGMP and biopharma Duties Individual contributor responsible to manage change control records and lead projects in support of Manufacturing Operations. This...
-
Quality Assurance Team Lead
4 weeks ago
Fremont, California, United States Stratosphere Quality Full timeh3Job Description/h3pStratosphere Quality is seeking a highly skilled Quality Assurance Team Lead to join our team. As a Quality Assurance Team Lead, you will be responsible for project setup, managing customer deliverables, and team member expectations. You will also be responsible for general supervision and ongoing training with the team to maintain...
-
Quality Assurance Team Lead
4 weeks ago
Fremont, California, United States Stratosphere Quality Full timeJob SummaryStratosphere Quality is seeking a highly skilled Quality Assurance Team Lead to oversee project setup, manage customer deliverables, and supervise team members. The ideal candidate will have a strong background in quality assurance and be able to lead teams to achieve consistent work and communication with customers and employees.Key...
-
Quality Assurance Specialist IV
4 weeks ago
Fremont, California, United States Fladger Assoc. Inc. Full timeFladger Assoc. Inc. is seeking a Quality Assurance Specialist IV to provide quality oversight of a GMP manufacturing facility in Fremont, CA.Responsibilities:Ensure compliance to clinical and commercial products cGMP regulations during manufacturing and facility operations.Collaborate in evaluation of identified issues, resolution and to ensure compliance...
-
Quality Assurance Specialist
2 months ago
Fremont, United States Asahi Kasei America Inc Full timeThe Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.Bionova is a...
-
Manufacturing Operations Specialist
4 weeks ago
Fremont, California, United States Adecco Full timeJob SummaryAdecco is seeking a skilled Manufacturing Technician to join our team. As a key member of our production team, you will be responsible for managing production schedules, ensuring timely completion of orders, and overseeing quality control processes. You will also train new employees on manufacturing procedures and safety protocols, troubleshoot...
-
Manufacturing Operations Specialist
4 weeks ago
Fremont, California, United States JobRialto Full timeJob Summary: JobRialto is seeking a skilled Manufacturing Technician I to execute fundamental unit operations in downstream manufacturing related to the production of bulk drug substances in a multi-product facility. This role involves performing tasks under limited supervision, adhering to standard operating and manufacturing procedures while maintaining...
-
Manufacturing Production Specialist
4 weeks ago
Fremont, California, United States Adecco Full timeJob Summary:Adecco is seeking a skilled Manufacturing Assembler to join our team. As a key member of our production team, you will be responsible for assembling manufactured parts according to specifications, inspecting finished products for quality assurance, and operating machinery and tools to complete the assembly process. Additionally, you will be...
-
Manufacturing Production Specialist
4 weeks ago
Fremont, California, United States Adecco US, Inc. Full timeAdecco is assisting a local client in Fremont, CA with a Manufacturing Technician position. The job is Temp to Hire with a salary of $22.00 per hour. Apply now for instant consideration.**Job Summary**The candidate will work as a Manufacturing Technician responsible for operating production equipment and assembling and packaging products by following...
-
Manufacturing Production Specialist
4 weeks ago
Fremont, California, United States Adecco US, Inc. Full timeAdecco US, Inc. is assisting a local client in the Fremont, CA area with a Temp to Hire opportunity for a Manufacturing Technician. The position offers a competitive hourly rate of $22.00 and a great work culture.Job SummaryThe Manufacturing Technician will be responsible for operating production equipment, assembling and packaging products, and maintaining...
-
Quality Assurance Specialist
4 weeks ago
Fremont, California, United States Hyve Solutions Full timeAbout the Role:At Hyve Solutions, we're seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality department, you'll play a vital role in ensuring the safety, quality, and compliance of our products.Key Responsibilities:Develop and implement inspection and testing protocols for raw materials, in-process materials,...
-
Manufacturing Process Development Specialist
4 weeks ago
Fremont, California, United States Tesla Full timeKey ResponsibilitiesWe are seeking a highly skilled Engineering Technician to join our Power Electronics & Energy Storage manufacturing team.As a key member of our team, you will work closely with cross-functional teams to drive continuous improvement, increase product performance, and enhance manufacturing productivity.Collaborate with engineers to develop,...
-
Quality Control Training Specialist II
1 month ago
Fremont, California, United States Penumbra Full timeJob Title: Quality Control Training Specialist IIPenumbra is seeking a highly skilled Quality Control Training Specialist II to join our team. This role will be responsible for developing and executing training programs to support the stability and growth of our Quality Inspection environments.Key Responsibilities:Develop and maintain current training...