Quality Assurance Analyst II

3 weeks ago

Rancho Cordova, United States Ampac Fine Chemicals Full time

SK pharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities. We are looking for a Quality Assurance Analyst II to join our CA team. This position is in-office.
JOB SUMMARY

Quality Assurance is responsible for the issuance of controlled documents (batch records, work instructions and product labels) to support production, release and shipment of products. Production records are completed by Operations staff and are then submitted to Quality Assurance as evidence of the execution of an approved process or procedure (Batch record or work instruction). Once production records have been executed, reviewed by Quality Assurance and assembled into the complete record they are stored per standard procedures for eventual retrieval to meet various customer, regulatory or internal needs.

DUTIES AND RESPONSIBILITIES

  • Issuance of controlled copies of batch records and work instructions to production.
  • Issuance or review of original labels for use by production and shipping.
  • Notify appropriate QA staff if an issue is observed that may require appropriate documentation and/or investigation and will work with the appropriate quality or production staff to resolve the issue.
  • Be responsible for the timely review of records, to include confirming the completeness of the record and the accuracy of relevant entries against primary documents or sources, confirmation that calculations were completed correctly, Ensuring parameters of time, temp, pressure, etc. have been met based on the entries in the production record.
  • Ensure the production records are completed in accordance with Good Documentation Practices. Communicate required corrections back to the production staff in a timely manner. Confirm any required corrections have been appropriately completed.
  • Immediately notify the appropriate QA Specialist of any observations that might require investigation under a formal deviation.
  • Release of equipment in accordance with reviewed production and testing records.
  • Work with the relevant QA Specialist to release intermediates as needed to support the production schedule at AFC.
  • Work with the relevant QA Specialist to support the release of final product.
  • Assemble the completed record for scanning and storage.
  • reconcile as appropriate the completed record with the issuance records.
  • Scan, and bind as appropriate the completed records and place them into document storage.
  • Be responsible for the organization and management of the QA document archive as appropriate.
  • Complete document disposition letters when stored records are to be prepared for disposal or transfer to a customer as appropriate
  • Be responsible to obtain and maintain appropriate training for the requirements of this role.
  • All responsibilities are to be carried out in accordance with approved company procedures and the requirements of CGMP.
DISCLAIMER

May perform other duties as assigned.

EDUCATION AND EXPERIENCE
  • An Associate’s degree is required for this position
  • A Bachelor’s degree is preferred for this position.
  • 6-9 years of relevant experience with an Associate’s degree.
  • 3-5 years of relevant experience with Bachelor’s degree.
COMPETENCIES/SKILLS
  • Strong attention to detail
  • Ability to work in a fast pace, team-oriented environment
  • Able to work independently when appropriate
  • Able to act with a sense of urgency, while maintaining accuracy and data integrity
  • General computer skills, working knowledge of Microsoft Office applications.
  • Have a working knowledge of CGMP.
CERTIFICATIONS and LICENSES
  • Not Applicable

  • Quality Assurance Analyst II

    3 weeks ago

    Rancho Cordova, United States AMPAC Fine Chemicals Full time $68,500 - $80,000

    Job DescriptionJob DescriptionSK pharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities. We are looking...

  • Quality Assurance Specialist II

    2 weeks ago

    Rancho Cordova, California, United States AMPAC Fine Chemicals Full time

    Job OverviewAMPAC Fine Chemicals is a leading provider of custom manufacturing solutions for active pharmaceutical ingredients (APIs) and intermediates, serving clients in the pharmaceutical sector. Our state-of-the-art facilities are dedicated to process innovation, scaling production, and adhering to cGMP standards for manufacturing from small to large...

  • Quality Assurance Analyst I

    2 months ago

    Rancho Cordova, United States AMPAC Fine Chemicals Full time

    Job DescriptionJob DescriptionSKpharmteco is a custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities located in California, Texas, and Virginia specialize in process development, scale-up, and cGMP compliant production from...

  • Quality Assurance Specialist

    2 days ago

    Rancho Cordova, California, United States AMPAC Fine Chemicals Full time

    Job DescriptionAMPAC Fine Chemicals is a leading custom manufacturer of active pharmaceutical ingredients (APIs, Drug Substances) and registered intermediates for customers in the pharmaceutical industry. Our integrated facilities specialize in process development, scale-up, and cGMP compliant production from kilograms to multi-ton quantities.Job Summary:As...

  • Quality Assurance Specialist

    2 weeks ago

    Rancho Cordova, California, United States Link Consulting Full time

    Job OverviewThe Quality Assurance Specialist will be instrumental in upholding and enhancing the quality management framework at Link Consulting Services. This role encompasses comprehensive oversight of quality documentation, ensuring adherence to industry regulations, and fostering continuous improvement efforts. The ideal candidate will possess...

  • Data Analyst I

    1 month ago

    Rancho Cordova, United States Turning Point Community Programs Full time

    Job DescriptionJob DescriptionGENERAL PURPOSEUnder the general supervision of the Director of Outcomes and Evaluations, this position is responsible for a wide variety of data analysis duties performed in conjunction with and assisting the Data Analyst II and Director of Outcomes and Evaluation.This is an at-will administrative position within the Home...

  • Quality Assurance Specialist

    2 weeks ago

    Rancho Cordova, California, United States Teledyne Full time

    Be a TrailblazerTeledyne Technologies Incorporated is at the forefront of providing essential technologies for industrial growth sectors that demand cutting-edge solutions and unwavering reliability. Our focus areas encompass aerospace and defense, factory automation, environmental monitoring of air and water quality, electronics design and development,...

  • Clinical Quality Analytics, Senior

    4 months ago

    Rancho Cordova, United States Blue Shield of California Full time

    Your Role The Clinical Quality Analytics and Informatics team delivers best-in-class clinical quality analytics and informatics to enable high quality and affordable member-centered care. Our data, intelligence, and actionable insights help drive quality strategy, performance improvement, and regulatory reporting. The Clinical Quality Analyst - Senior...

  • Quality Assurance Specialist

    1 week ago

    Rancho Cordova, California, United States Tri Tool Inc Full time

    Job Summary: Tri Tool Inc is seeking a skilled Quality Control Inspector to ensure the highest quality standards in our manufacturing process.About the Role: As a Quality Control Inspector, you will be responsible for conducting manual inspections of machined parts, verifying product compliance with drawings and specifications, and inspecting products at...

  • Business Analyst II

    1 month ago

    Rancho Cordova, California, United States FIS Global Full time

    Position Type : Full time Type Of Hire : Experienced (relevant combo of work and education) Education Desired : Bachelor of Business Administration Travel Percentage : 0%Job DescriptionAre you curious, motivated, and forward-thinking? At FIS you'll have the opportunity to work on some of the most challenging and relevant issues in financial services and...

  • Quality Assurance Manager

    7 days ago

    Rancho Cucamonga, California, United States Gentex Corporation Full time

    About the RoleGentex Corporation is a leading provider of personal protection and situational awareness solutions for defense forces, emergency responders, and industrial personnel operating in high-performance environments.As a Quality Assurance Manager, you will play a critical role in ensuring the quality of our products and services, while also driving...

  • Quality Assurance Manager

    2 weeks ago

    Rancho Cucamonga, California, United States Gentex Corporation Full time

    COMPANY OVERVIEW:Gentex Corporation is a prominent entity with over 130 years of expertise, specializing in personal protection and situational awareness solutions tailored for defense forces, emergency responders, and industrial personnel in high-performance settings. Our multinational workforce is dedicated to innovative projects that not only enhance...

  • Quality Assurance Manager

    2 weeks ago

    Rancho Cucamonga, California, United States Gentex Corporation Full time

    COMPANY OVERVIEW:At Gentex Corporation, we foster an environment where innovative ideas and talented individuals can excel. With a legacy of over 130 years, Gentex stands as a global frontrunner in personal protection and situational awareness solutions tailored for defense forces, emergency responders, and industrial personnel in high-performance settings....

  • Clinical Quality Analytics Lead

    7 days ago

    Rancho Cordova, California, United States Blue Shield of California Full time

    About the RoleThe Clinical Quality Analytics and Informatics team at Blue Shield of California is seeking a highly skilled Senior Clinical Quality Analyst to join our team. As a Senior Clinical Quality Analyst, you will play a critical role in delivering best-in-class clinical quality analytics and informatics to enable high-quality and affordable...

  • Quality Assurance Specialist

    7 days ago

    Rancho Cucamonga, California, United States Amtec Contract Full time

    Quality Assurance Specialist Position at Amtec ContractJob Summary:The Quality Assurance Specialist is responsible for inspecting production articles to ensure they meet specifications at inspection or production stations.Key Responsibilities:Review technical documents and specifications to gather product details such as materials, surface finishes, and...

  • Quality Assurance Specialist

    6 days ago

    Rancho Cucamonga, California, United States Amtec Contract Full time

    Quality Assurance Specialist Position at Amtec ContractJob Overview:The Quality Assurance Specialist is tasked with evaluating production items to confirm they conform to established standards at inspection or manufacturing points.Key Responsibilities:Examine technical drawings and engineering guidelines to collect product information such as materials,...

  • Structural Integrity Assurance Inspector

    7 days ago

    Rancho Cordova, California, United States gpac Full time

    Job Overview Position Summary: The Structural Integrity Assurance Inspector is tasked with supervising the implementation of the Quality Assurance/Quality Control Program. This includes conducting inspections, overseeing welding procedures, managing material receipt, performing audits, and maintaining documentation within a diverse metals and steel...

  • Quality Assurance Inspector

    7 days ago

    Rancho Cucamonga, California, United States CG Staffing Solutions Full time

    Job OverviewThe role of a Quality Assurance Inspector is essential in ensuring that products meet stringent quality standards within a manufacturing or production setting.Key ResponsibilitiesEvaluate and inspect products to ensure they meet specified quality standards.Interpret and analyze blueprints and technical drawings.Utilize precision measuring...

  • Public Service Management Analyst

    2 weeks ago

    Rancho Cordova, California, United States City of Rancho Cordova Full time

    Salary: $83, $112,590.36 AnnuallyPOSITION OVERVIEWAre you a proactive individual with a knack for innovative problem-solving? The City of Rancho Cordova seeks a skilled and enthusiastic professional to contribute to the development and management of community-focused initiatives. This role requires a blend of creativity, independence, and a passion for...

  • Structural Quality Control Inspector

    1 month ago

    Rancho Cordova, California, United States gpac Full time

    SummaryThe Quality Control Inspector / Coordinator is responsible to oversee the application of the Quality Assurance/Quality Control Program, including inspections, weld procedures, material receiving, audits, paperwork, working in a misc. Metals and Steel fabrication shop environment, being involved in 'Code Work' and auditing of all QC paperwork prior to...