Quality Expert

Found in: Appcast Linkedin GBL C2 - 2 weeks ago


Rocklin, United States Integrated Resources, Inc ( IRI ) Full time

Job Title: Quality Assurance Expert

Job Location: Rocklin, CA

Job Duration: 12 Months


Job Description:

Preferred: Bachelor’s degree in any life science, GMP, Pharma industry experience At least 1 year of experience 100% on-site Ideal candidate has reviewed docs in a GMP setting or worked in a quality role in a GMP setting.

Energetic, quick learner, excellent attention to detail technical documentation for product design - PLUS


Primary objective of position:

  • The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system.
  • This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality manual.
  • This position is multi-disciplinary with opportunities to work on future products and current product and process improvements.
  • The position may represent Quality on cross-functional teams to support business needs driving a positive site quality culture.
  • The position prepares Quality System documents and reports as needed for Rocklin site metrics and management review.


Job responsibilities:

  • Directly responsible for ensuring documents submitted to Quality are compliant to company procedures, regulatory requirements, and the quality manual.
  • Performs project review and audit of Device History Files (DHF’s) and technical files including:
  • Stability protocols and reports
  • Summary of Safety and Performance reports o Risk Management plans, reports, FMEAs o Post-Market Surveillance plans and reports o Performance evaluation plans and reports including scientific, clinical, and analytical documents.
  • Product composition reports
  • Sensitivity and specificity/Repeatability and reproducibility reports o Specification reports o General Safety and Performance Requirement reports o Etc.
  • Performs review of data and records supporting the DHF while assessing for good documentation and record keeping practices ensuring appropriate requirements are met.
  • Obtains information for clarification from process owners while providing appropriate and relevant feedback.
  • Coordinates files upon completion of review for upload into EDMS as necessary.
  • Electronically signs as technical approver for quality on applicable documents and within the validated electronic databases.
  • Write, revise and/or review Standard Operating Procedures.
  • Maintain extensive knowledge of Standard Operating Procedures and policies.
  • Supports internal and external audits as required.
  • Understands, supports, and communicates Company mission, vision, and values.
  • Understands and follows the requirements of the quality system.
  • Maintains current training requirements.
  • Trains other staff members as requested.
  • Adhere to regulatory requirements (including cGMP), standards, procedures, and company policies.
  • Recommends, provides, or initiates solutions by actively providing suggestions for improvement.
  • Must be willing and able to work on weekends or extended hours as needed.
  • Follows regulatory and standard requirements as applicable to the site, i.e. MDSAP, ISO 13485, IVDD/IVDR, and compliance to the site Quality Manual.
  • Review and approve quality documentation and records.
  • Collaborates and coordinates with internal stakeholders to identify, escalate, and resolve quality issues.
  • Other duties as assigned or required.



  • Rocklin, United States Integrated Resources, Inc Full time

    Job Title: Quality Assurance Expert Job Location: Rocklin, CA Job Duration: 12 Months Looking for an organized individual that has basic Laboratory and Quality experience. Time: 40 hours a week, swing shift 2 pm - 10 pm Pay Range: $25 - $27/hr on W2. Job Description: · The Quality Technician is responsible...

  • Quality Control Expert 1

    Found in: Appcast US C2 - 2 weeks ago


    Rocklin, United States JobsRUs.com Full time

    JobsRUs.com is seeking to hire a Quality Control Expert for our client in Rocklin, CA! Pay rate: 23.00 - 25.00Quality Control TechnicianPRIMARY OBJECTIVE OF POSITION:Under supervision, the Quality Control (QC) Technician performs laboratory activities in the QC labincluding inventory tracking, ordering maintenance, bio burden, slide filling, and IHC;...


  • Rocklin, United States JobsRUs.com Full time

    JobsRUs.com is seeking to hire a Quality Control Expert for our client in Rocklin, CA! Pay rate: 23.00 - 25.00Quality Control TechnicianPRIMARY OBJECTIVE OF POSITION:Under supervision, the Quality Control (QC) Technician performs laboratory activities in the QC labincluding inventory tracking, ordering maintenance, bio burden, slide filling, and IHC;...


  • Rocklin, United States JobsRUs Full time

    Job DescriptionJob DescriptionJobsRUs.com is seeking to hire a Quality Control Expert for our client in Rocklin, CA! Pay rate: 23.00 - 25.00Quality Control TechnicianPRIMARY OBJECTIVE OF POSITION:Under supervision, the Quality Control (QC) Technician performs laboratory activities in the QC labincluding inventory tracking, ordering maintenance, bio burden,...


  • Rocklin, United States JobRialto Full time

    Description : The Associate Quality Systems Specialist will be part of the Quality team and responsible for providing quality support for the site quality management system. This position ensures compliance of the quality system with regulations relevant to the business, including but not limited to, ISO13485, MDSAP, IVDD/IVDR, CFR 21, GxP, and the quality...


  • Rocklin, United States EMD (Merck KGaA) Full time

    is seeking to hire a Quality Control for our client in Rocklin, CA! Pay: $26-$28/hr.Monitors and documents that procedures, processes, equipment, and systems meet specifications and quality standards. Drives improvement of processes and procedures. IMPACT: Impacts the results of own team with own contributions. COMPLEXITY: Performs routine assignments using...


  • Rocklin, United States JobsRUs.com Full time

    JobsRUs.com is seeking to hire a Quality Control for our client in Rocklin, CA! Pay: $26-$28/hr.Monitors and documents that procedures, processes, equipment, and systems meet specifications and quality standardsDrives improvement of processes and proceduresIMPACT: Impacts the results of own team with own contributionsCOMPLEXITY: Performs routine assignments...


  • Rocklin, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Quality Control Expert Location: Rocklin, CADuration: 12 months+Note:A Quality Control analyst eager to be a part of a collaborative team. This role will focus on testing product to support business need including batch release, investigative testing, and validation. Previous immunohistochemistry and ELISA experience sought after.Monitors and...

  • Quality Control Analyst

    Found in: Appcast Linkedin GBL C2 - 4 days ago


    Rocklin, United States Integrated Resources, Inc ( IRI ) Full time

    Title: Quality Control Expert Location: Rocklin, CADuration: 12 months+Note:A Quality Control analyst eager to be a part of a collaborative team. This role will focus on testing product to support business need including batch release, investigative testing, and validation. Previous immunohistochemistry and ELISA experience sought after.Monitors and...

  • Quality Assurance Specialist

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago


    Rocklin, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Quality Assurance Expert ILocation: Rockling, CABenefits: Medical, Dental, Vision, and Life InsurancePay Rate: $27.00 - $30.00 Hour DOEShift: Mon – Fri 8:00 AM to 5:00 PMTerm: 12-month contract with possible extensions or permanency (Based on Performance)Requirements: High School Diploma or GED / 1-year experience. /...

  • Quality Assurance Specialist

    Found in: Appcast US C2 - 2 weeks ago


    Rocklin, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Quality Assurance Expert ILocation: Rockling, CABenefits: Medical, Dental, Vision, and Life InsurancePay Rate: $27.00 - $30.00 Hour DOEShift: Mon – Fri 8:00 AM to 5:00 PMTerm: 12-month contract with possible extensions or permanency (Based on Performance)Requirements: High School Diploma or GED / 1-year experience. /...


  • Rocklin, United States CareerBuilder Full time

    Job Title: Process Engineering Specialist/Process Engineering & Validation Expert 1 Location: 95677, Rocklin, California, United States Duration: 12 Months Job Description: Roles related to the design, production and maintenance of structures, systems and components in production plants and facilities. Develops and applies engineering standards and...

  • Home Infusion RN HOME HEALTH NURSE 2

    Found in: beBee S US - 2 days ago


    Rocklin, United States UC Davis Health System Full time

    Department Description The role of the Home Infusion Nurse Liaison is to provide exemplary infusion care to patients. Home Infusion RNs are experts in vascular access care and employ a wide range of techniques to ensure patients receive an exceptional care experience. Home Infusion RNs provide standard and progressive infusion therapies such as antibiotics,...

  • Home Infusion RN HOME HEALTH NURSE 2

    Found in: beBee jobs US - 2 days ago


    Rocklin, California, United States UC Davis Health System Full time

    Department Description The role of the Home Infusion Nurse Liaison is to provide exemplary infusion care to patients. Home Infusion RNs are experts in vascular access care and employ a wide range of techniques to ensure patients receive an exceptional care experience. Home Infusion RNs provide standard and progressive infusion therapies such as antibiotics,...

  • Assisted Living Coordinator

    Found in: Resume Library US A2 - 4 days ago


    Rocklin, California, United States Sunrise Senior Living Full time

     : Sunrise Senior Living was again certified as a Great Place to Work® by Activated Insights. This is the 6th time Sunrise has received this top culture and workplace designation, highlighting the special place Sunrise is to be a part of. COMMUNITY NAME: Sunrise of Rocklin Job ID: (phone number removed) JOB OVERVIEW: "Sunrise is the best place that...