Current jobs related to GxP Supplier Quality Contractor - South San Francisco, California - American Cybersystems, Inc.
-
GxP Supplier Quality Assurance Specialist
1 week ago
San Francisco, California, United States Harvest Technical Services Full timeMain Objective of the RoleAssist External Quality GxP Supplier Quality Managers in maintaining adherence to cGMP and Quality Agreement stipulations.Oversee assigned suppliers and engage in cross-functional teams for supplier lifecycle management.Facilitate various quality initiatives throughout the lifecycle of GxP suppliers.Establish and uphold risk-based...
-
Vice President, Quality Assurance and Compliance
12 hours ago
South San Francisco, California, United States Hibio Full timeAbout the RoleWe are seeking a seasoned Quality Professional to join our team at Hibio, Inc. as Vice President, Quality Assurance and Compliance. This is a critical role that will oversee and participate in the development, implementation, and maintenance of quality management practices and systems to ensure compliance with internal policies, business...
-
Senior Vice President of Quality Management
1 week ago
South San Francisco, California, United States Hibio Full timePOSITION TITLE: Senior Vice President of Quality ManagementDEPARTMENT: Regulatory AffairsEMPLOYMENT TYPE: Full-TimeHI-Bio, Inc. is a pioneering biotechnology firm located in South San Francisco, California. Our mission is to revolutionize the treatment of patients suffering from severe immune-mediated disorders by developing innovative targeted therapies...
-
Senior Vice President of Quality Management
1 week ago
South San Francisco, California, United States Hibio Full timePOSITION TITLE:Senior Vice President of Quality ManagementDIVISION:Regulatory AffairsEMPLOYMENT TYPE:Full-TimeHI-Bio, Inc. is a pioneering biotechnology firm located in South San Francisco, California. Our collective mission is to revolutionize the treatment of patients suffering from severe immune-mediated disorders by creating innovative targeted therapies...
-
Head of Clinical Quality Assurance
3 days ago
South San Francisco, California, United States Abdera Therapeutics Full timeAbdera Therapeutics Inc. - Director of Quality in Clinical OperationsAbdera Therapeutics Inc. is at the forefront of precision oncology, focusing on innovative radiation therapies. We are looking for a Director of Quality in Clinical Operations to oversee quality management for our cutting-edge oncology clinical initiatives.Key Responsibilities:Oversee...
-
Senior Quality Manager for Suppliers
4 days ago
San Jose, California, United States Semiconductor Components Industries, LLC Full timeAbout Semiconductor Components Industries, LLCSemiconductor Components Industries, LLC is a leading global semiconductor manufacturer dedicated to providing high-quality products and services. As the Senior Director of Supplier Quality, you will be instrumental in ensuring the excellence of our supply chain. This includes the development of supplier quality...
-
Head of Supplier Quality Strategy
1 week ago
San Jose, California, United States Semiconductor Components Industries, LLC Full timeCompany OverviewSemiconductor Components Industries, LLC is a leading global manufacturer in the semiconductor sector, dedicated to providing superior products and services. In the role of Senior Director of Supplier Quality, you will be instrumental in guaranteeing the excellence of our supply chain. This includes the development of supplier quality...
-
Senior Supplier Quality Engineer
2 months ago
San Jose, California, United States Archer Aviation Full timeArcher Aviation is a forward-thinking aerospace company situated in San Jose, California. Our primary focus is on crafting an innovative all-electric vertical takeoff and landing aircraft to promote sustainable air mobility. At Archer, we tackle challenging problems with high ambitions, and we strongly believe that a diverse workforce enhances our...
-
Supplier Quality Assurance Engineer
1 week ago
San Jose, California, United States Bayone Full timePosition Overview:As a key member of the Supply Chain Program Management team at Bayone, you will engage with supplier quality engineering to ensure the successful execution of quality-related objectives.Key Responsibilities:Lead the completion of essential supplier quality tasks, including audits, Advanced Product Quality Planning (APQP), tooling readiness...
-
Senior Vice President of Quality Assurance
1 week ago
South San Francisco, California, United States Annexon Bioscience Full timeWork Location Corporate Headquarters - Hybrid Position Overview Annexon Biosciences is in search of a Senior Vice President of Quality Assurance who will take charge of comprehensive Quality responsibilities, encompassing the leadership of GMP, GCP, and GLP operations. This role entails overseeing the formulation, execution, and upkeep of quality management...
-
Quality Assurance Analyst
1 week ago
South San Francisco, California, United States Planet Pharma Full timePosition OverviewThe Quality Assurance Analyst will play a crucial role in ensuring compliance with industry standards and regulations within the quality management framework.Key ResponsibilitiesOversee daily functions of Quality Systems and Document Control to uphold regulatory compliance.Assist in the execution of projects aimed at enhancing quality...
-
Quality Control Analyst
1 week ago
South San Francisco, California, United States Planet Pharma Full timeContract Opportunity - Maternity Leave CoverageOnsite Role - Full-TimeCompensation: $40 - $50 per hourKey ResponsibilitiesOversee daily functions of Quality Management Systems (Veeva Vault) and Document Control to ensure adherence to regulatory and company standards.Assist in initiatives aimed at enhancing quality systems.Contribute to the employee training...
-
Quality Control Specialist
1 week ago
South San Francisco, California, United States Planet Pharma Full timeContract Opportunity - Covering for a Maternity LeaveOnsite Position - 5 Days a WeekCompensation: $40 - $50 per HourKey ResponsibilitiesOversee daily functions of Quality Systems (Veeva Vault) and Document Control to ensure adherence to regulatory and company standards.Assist in the execution of projects aimed at enhancing quality systems.Support the...
-
Manager, Quality Control
2 months ago
South San Francisco, California, United States Cellares Full timePosition SummaryWe are seeking an innovative and highly motivated individual to join our team as the Manager of Quality Control at our GMP manufacturing facility located in South San Francisco, CA. This position will work with the Quality Control team in supporting our efforts in the GMP manufacturing of cellular therapy products.This is a multidisciplinary...
-
Senior Supplier Quality Engineer
3 days ago
San Diego, California, United States Lockheed Martin Full timeJob DescriptionJob Summary:Lockheed Martin is seeking a highly skilled Senior Supplier Quality Engineer to join our team. As a key member of our Supply Chain Quality team, you will be responsible for ensuring the quality and overall management of procured products and services at our facilities.Key Responsibilities:Lead and manage the Supplier Quality...
-
Vendor Quality Management Lead
1 week ago
San Diego, California, United States Arrowhead Pharmaceuticals Full timeCompany OverviewArrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization dedicated to developing innovative therapies for challenging diseases through gene silencing technologies. Our commitment to advancing RNA interference (RNAi) therapeutics positions us at the forefront of addressing genetic disorders across various therapeutic...
-
Vendor Quality Management Lead
1 week ago
San Diego, California, United States Arrowhead Pharmaceuticals Full timeCompany OverviewArrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization focused on developing innovative therapies that target intractable diseases through gene silencing. Utilizing advanced RNA chemistries and effective delivery mechanisms, Arrowhead's treatments activate the RNA interference process to achieve significant and lasting...
-
Estimating Professional
21 hours ago
San Francisco, California, United States Jobot Full timeAbout the RoleWe are seeking an experienced Estimator to join our team at Jobot, a leading General Contractor in the Bay Area. As an Estimator, you will play a critical role in preparing accurate quantity takeoffs and materials pricing, coordinating subcontract solicitations and job walks, and determining labor and construction equipment...
-
Supplier Quality Assurance Engineer
1 week ago
San Diego, California, United States Oura Full timeAbout Oura:At Oura, we are dedicated to enabling individuals to unlock their true potential. Our innovative products provide our global community with insights into their readiness, activity, and sleep quality through the Oura Ring and its accompanying app.With over one million users benefiting from our daily insights, we are committed to inspiring healthier...
-
Vendor Quality Management Lead
1 week ago
San Diego, California, United States Arrowhead Pharmaceuticals Full timeCompany OverviewArrowhead Pharmaceuticals, Inc. is a pioneering biopharmaceutical organization dedicated to developing innovative therapies aimed at treating challenging diseases through gene silencing. Utilizing advanced RNA chemistry and effective delivery mechanisms, Arrowhead's treatments activate the RNA interference process to achieve significant and...
![American Cybersystems, Inc.](https://media.trabajo.org/img/noimg.jpg)
GxP Supplier Quality Contractor
1 month ago
Position type: Full time Contract.
Duration: 12 months
Location: South San Francisco, CA
As a GxP Supplier Quality Contractor, you will:
Job Description:
Main Purpose of the Position Support External Quality GxP Supplier Quality Managers in the following key aspects of their role:
Provide quality and compliance oversight for external GxP suppliers including CMO CLO suppliers or distributors of direct materials or critical process-contacting spare parts suppliers for analytical equipment or manufacturing systems and service providers to ensure compliance with cGMP and Quality Agreement requirements
Manage designated suppliers and participate as part of GxP supplier cross-functional management teams to enable as applicable for the supplier lifecycle stage site selection and implementation including due diligence activities ongoing quality supply of commercial products materials or services from suppliers and decommissioning.
Technical Job Responsibilities:
Support External Quality GxP Supplier Quality Managers in the following activities associated with their role:
Oversee all required quality activities during the lifecycle of a GxP supplier Source Select Implement
Manage and Decommission including but not limited to: process or method validations client and Health Authority audits complex investigations market complaints and regulatory submissions
Develop negotiate and maintain risk-based Quality Agreements and Product Specific Requirements as appropriate with GxP suppliers and ensure compliance with agreements
Collaborate with GxP suppliers to address gaps of audit responsiveness CAPA implementation deviation reporting and management complaint management investigation closure and change implementation with regard to quality and time with the supplier and escalate as appropriate
As applicable collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods SAM in a validated state and compliant with the regulatory dossier including stability testing programs
As applicable develop and maintain quality risk management plans utilize risk management tools to identify and mitigate supplier quality and compliance risks ensuring suppliers are in a state of continuous inspection readiness
As applicable support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify design and implement process and system improvements.
This includes support for implementation of or changes to enterprise-wide systems such as SAP Veeva and MDMS/GLAS.
Functional Job Responsibilities
Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with client objectives.
Notify relevant GxP Supplier Quality Managers and/or Senior Management of potential quality or regulatory issues impacting product quality or regulatory compliance.
Troubleshoot and drive the resolution of quality issues fostering effective interdepartmental and cross-functional partnerships.
Sign documents as authorized and described by Client policies procedures and job descriptions. Be accountable for behaviors described in client Code of Conduct. Deliver business outcomes in support of departmental objectives.
Maintain and communicate work priorities to meet goals and timelines. Timely complete all job-related training requirements before performing GMP-job functions and strive to continuously improve knowledge and skills in quality compliance and technology.
Perform other quality-related activities and projects to ensure quality compliance and continuous improvement. Train other interns as required
Qualifications and Skills
B.A. or B.S. degree in life sciences or equivalent Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus
Ability to interpret quality standards as they relate to GxP suppliers Operational Excellence expertise is a plus
Highly competent in MS Office or Google Suite applications including Excel PowerPoint Word and MS Project etc.
Ability to communicate clearly and professionally both in writing and verbally
Note:
They are looking to find a contractor with QC experience within these levels: Level II 3-5 Years experience Level III 5-7 Years experience
Qualified candidates should APPLY NOW for immediate consideration Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.
We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.
Thank you
Namrata Gautam
Senior Associate Recruitment
PHONE:
EMAIL:
PAY RANGE AND BENEFITS:
Pay Range*: $65- $77 per hour.
*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.
Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).
ABOUT INNOVA SOLUTIONS:Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.
Recent Recognitions:
- One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
- ClearlyRated Client Diamond Award Winner
- One of the Largest Certified MBE Companies in the NMSDC Network
- Advanced Tier Services partner with AWS and Gold with MS
Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.