Sr. Specialist Quality Assurance

13 hours ago

san diego, United States Proclinical Staffing Full time

Sr. Specialist Quality Assurance - Contract - San Diego CA

Proclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents.

Primary Responsibilities:

This role involves managing and archiving quality-controlled documents and records for GMP, GLP, and GCP. The successful candidate will also support GXP managers in creating training matrices for new employees and maintain training records. This role will also maintain the approved supplier list and participate in batch record reviews and approvals.

Skills & Requirements:

  • Knowledge of GMP, GCP, and GDP regulatory requirements.
  • Experience with EDMS or EQMS is preferred.
  • Self-motivated with excellent organizational skills and the ability to prioritize effectively.
  • Ability to work and make decisions independently and as part of a team.
  • Strong verbal, interpersonal, and written communication skills.
  • Strong collaboration, strategic thinking, leadership, and teamwork skills.
  • Advanced computer skills.

The Sr. Specialist Quality Assurance's responsibilities will be:

  • Manage document control, change control, and training processes for GXP activities.
  • Prepare and handle documents and procedures for review, approval, and execution.
  • Develop, review, and revise documentation procedures.
  • Establish and maintain records management processes, including archival and retention of key documents and protocols.
  • Ensure operational and validation status of EQMS and DocuSign Part 11 systems.
  • Handle and track change control activities, ensuring timely approval and closure.
  • Oversee onboarding and ongoing training programs, tracking and maintaining training records.
  • Recommend improvements and changes to quality processes.
  • Attend CMC and Clinical Sub team meetings as a QA representative.
  • Help prepare metrics information for GMP using EQMS summary functions.
  • Perform other duties as assigned.

If you are having difficulty in applying or if you have any questions, please contact Bodin Forsen at B.Forsen@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

INDQA

  • Sr. Specialist Quality Assurance

    23 hours ago

    San Diego, United States Proclinical Staffing Full time

    Sr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...

  • Sr. Specialist Quality Assurance

    4 hours ago

    san diego, United States Proclinical Staffing Full time

    Sr. Specialist Quality Assurance - Contract - San Diego CAProclinical is seeking a Sr. Specialist Quality Assurance to oversee and manage document control activities, including deviations, change control, training, and maintenance of documents. Primary Responsibilities:This role involves managing and archiving quality-controlled documents and records for...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Jobot Full time

    Quality Assurance Specialist Needed For Innovative and Growing Space and Optical Engineering CompanyThis Jobot Job is hosted by a reputable staffing agency specializing in placing top talent in the aerospace industry.We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for...

  • Quality Assurance Specialist

    2 months ago

    San Diego, California, United States Jobot Full time

    Quality Assurance Specialist Needed For Innovative and Growing Space and Optical Engineering CompanyThis Jobot Job is hosted by a reputable staffing agency specializing in placing top talent in the aerospace industry.We are seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Top Dogg Staffing Full time

    Quality Assurance SpecialistThe Position Quality Assurance Specialist (Medical Device-Spine) Medical Equipment / Devices Information Technology - Quality AssuranceFull-time United States - California - San Diego - Vista The Compensation $ 80,000 -$91,000 Benefits - FullRelocation Assistance Available - NoCommission Compensation - No Bonus Eligible - Yes...

  • Quality Assurance Specialist

    1 week ago

    San Diego, California, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistAbout the Role:We are seeking a Quality Assurance Specialist to join our team at Insight Global. As a Quality Assurance Specialist, you will be responsible for designing and conducting quality assurance testing to support improvement initiatives for various business systems.Key Responsibilities:* Review requirements and...

  • Quality Assurance Specialist

    1 week ago

    San Diego, California, United States Kratos Defense & Security Solutions Full time

    Job Summary:Kratos Defense & Security Solutions is seeking a Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for designing, developing, and executing quality assurance and control systems.Key Responsibilities:Design and develop quality assurance and control systemsImplement quality concepts,...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States gategroup Full time

    Job SummaryWe are seeking a highly motivated and detail-oriented Quality Assurance Specialist to join our team at gategroup. As a Quality Assurance Specialist, you will be responsible for ensuring the highest standards of quality and safety in our Hot Foods Production department.Key ResponsibilitiesConduct temperature checks on products and ensure compliance...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Aerotek Full time

    **Quality Assurance Specialist**At Aerotek, we're seeking a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the highest quality standards are met in our manufacturing processes. Your expertise will be crucial in developing and maintaining CMM programs, performing product...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States CalTek Staffing, Inc. Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at CalTek Staffing, Inc. The ideal candidate will have a strong technical background in mass production processes and quality assurance for the telecommunications industry. This role involves overseeing the end-to-end production and design process, driving continuous...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Aerotek Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Aerotek. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of our products and processes by performing inspections and implementing effective solutions.Key Responsibilities:Develop and maintain CMM programs for inspecting and...

  • Quality Assurance Specialist

    4 weeks ago

    San Diego, California, United States Unavailable Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Unavailable. The successful candidate will be responsible for ensuring the highest quality standards in our products and processes.Key ResponsibilitiesEstablish Quality Standards: Develop and implement quality standards for products and processes to prevent defects...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States The Swag Bag Team Full time

    Job OverviewWe are seeking a skilled Quality Assurance Specialist to join our dynamic team at The Swag Bag Team. As a key member of our software development lifecycle, you will play a crucial role in ensuring the quality and reliability of our products.Key ResponsibilitiesReview and analyze system specifications to ensure clarity and understanding of...

  • Quality Assurance Specialist

    1 week ago

    San Diego, California, United States Wondfo USA Full time

    Job DescriptionWondfo USA is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a critical role in ensuring that our medical devices meet the highest quality standards and regulatory requirements.Key Responsibilities:Support and comply with the company's Quality Management System policies...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Insight Global Full time

    Job Title: Quality Assurance SpecialistA medical device enterprise company is seeking a Quality Assurance Specialist to join their team.The Quality Assurance Specialist is responsible for designing and conducting quality assurance testing that supports improvement initiatives for various Business Systems.This team is focused on the Service work stream which...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Innoflight LLC Full time

    Job OverviewInnoflight LLC is seeking a highly skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will play a crucial role in driving quality resolutions and implementing processes to enhance product quality.Key Responsibilities:Supports Quality Initiatives: Collaborate with Quality, Engineering, and Operations...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States Aerotek Full time

    Job Title: Quality Assurance SpecialistJob DescriptionAerotek is seeking a Quality Assurance Specialist to support efforts to ensure customer requirements are met and improve quality of products and processes throughout the organization. The successful candidate will perform inspections, identify areas for improvement, and implement effective solutions in...

  • Sr. Quality Assurance Specialist, External Manufacturing

    2 weeks ago

    San Carlos, California, United States Vaxcyte Full time

    About VaxcyteVaxcyte is a clinical-stage vaccine innovation company dedicated to protecting humankind from the consequences of bacterial diseases. Our mission is to eradicate or treat bacterial infections that have serious and costly health consequences when left unchecked.Job SummaryThe Sr. Quality Assurance Specialist, External Manufacturing will play a...

  • Quality Assurance Specialist

    2 weeks ago

    San Diego, California, United States MILLENNIUMSOFT Full time

    Job Title – Quality Assurance SpecialistLocation – RemoteDuration – 6+ Months ContractClient: Medical Device CompanyEmployment Type: Contract on W2 (Need US Citizens Or GC Holders Only)Job Summary:MILLENNIUMSOFT is seeking a Quality Assurance Specialist to join our team. The successful candidate will be responsible for remediating Risk Management Files...

  • Software Quality Assurance Specialist

    1 week ago

    San Diego, California, United States MILLENNIUMSOFT Full time

    Job SummaryAt MillenniumSoft, we are seeking a highly skilled Software Quality Assurance Specialist to join our team. The ideal candidate will have a strong background in software quality concepts and experience in developing, publishing, and implementing test plans.Key Responsibilities Ensures quality is built into software development products by utilizing...