... analytical lab instruments, and the Metasys Client. * By maintaining data integrity and system ... Manage system change control, deviations, and CAPAs related to validated systems, ensuring ...
61 Katalyst Quality Control Analyst Jobs Hiring Near You
... analytical lab instruments, and the Metasys Client. * By maintaining data integrity and system ... Manage system change control, deviations, and CAPAs related to validated systems, ensuring ...
QC Analyst
$24.50 - $32.75/hr
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also ...
QC Analyst
$24.50 - $32.75/hr
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also ...
Quality Control Analyst
$22.50 - $30/hr
Quality Control Analyst Candidates shall work to support requirements for PR0001 Program Support and will review and analyze the curriculum and substance of in-person, Webinar, and small group ...
Quality Control Analyst
$22.50 - $30/hr
Quality Control Analyst Candidates shall work to support requirements for PR0001 Program Support and will review and analyze the curriculum and substance of in-person, Webinar, and small group ...
QC Analyst
$45K - $75K/yr
Quality Control Analyst (PCR) 3rd shift 4-10s (M-Thur) This role focuses on performing routine and project-based qPCR testing to support in-process and finished product quality control in a GMP ...
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QC Analyst
$45K - $75K/yr
Quality Control Analyst (PCR) 3rd shift 4-10s (M-Thur) This role focuses on performing routine and project-based qPCR testing to support in-process and finished product quality control in a GMP ...
Quality Control Analyst
$45K - $75K/yr
Quality Control Analyst 3rd shift 4-10s (M-Thur) This role focuses on performing routine and project-based qPCR testing to support in-process and finished product quality control in a GMP ...
Quick apply
Quality Control Analyst
$45K - $75K/yr
Quality Control Analyst 3rd shift 4-10s (M-Thur) This role focuses on performing routine and project-based qPCR testing to support in-process and finished product quality control in a GMP ...
Quality Control Analyst
Salt Lake City, UT · On-site
$23.25 - $31.25/hr
The Quality Control Analyst provides analytical expertise to the laboratories regarding the department Quality Control program. Evaluates and implements protocols and methods of quality control to ...
Quality Control Analyst
Salt Lake City, UT · On-site
$23.25 - $31.25/hr
The Quality Control Analyst provides analytical expertise to the laboratories regarding the department Quality Control program. Evaluates and implements protocols and methods of quality control to ...
Quality Control Analyst
South Jordan, UT · On-site
$22.75 - $30.50/hr
The Quality Control Analyst provides analytical expertise to the laboratories regarding the department Quality Control program. Evaluates and implements protocols and methods of quality control to ...
Quality Control Analyst
South Jordan, UT · On-site
$22.75 - $30.50/hr
The Quality Control Analyst provides analytical expertise to the laboratories regarding the department Quality Control program. Evaluates and implements protocols and methods of quality control to ...
QC Analyst
$24.50 - $32.75/hr
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also ...
QC Analyst
$24.50 - $32.75/hr
The Quality Microbial Control Analyst V will act as a team member of the Quality Microbial Control department to support production of in-process and final product drug lots for customers. Also ...
QC Analyst
Lebanon, IN · On-site
$23 - $31/hr
My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a QC Analyst - Master Data (LI MS) based in Lebanon, IN with one of our prestigious clients.
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QC Analyst
Lebanon, IN · On-site
$23 - $31/hr
My name is Vyshu, and I'm reaching out from Intellectt Inc. regarding an exciting contract opportunity for a QC Analyst - Master Data (LI MS) based in Lebanon, IN with one of our prestigious clients.
QC Analyst
Los Angeles, CA · On-site
$25.75 - $34.75/hr
Position Overview The QC Analyst is an analytical, process driven, and detail-oriented professional responsible for supporting Arixa Capital's data quality across the loan lifecycle. This role ...
QC Analyst
Los Angeles, CA · On-site
$25.75 - $34.75/hr
Position Overview The QC Analyst is an analytical, process driven, and detail-oriented professional responsible for supporting Arixa Capital's data quality across the loan lifecycle. This role ...
QC Analyst
Los Angeles, CA · Hybrid
$25.75 - $34.75/hr
The QC Analyst will analyze data for consistency, identify discrepancies, correct mistakes, and provide feedback and training to the operational teams to avoid future inconsistencies. This position ...
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QC Analyst
Los Angeles, CA · Hybrid
$25.75 - $34.75/hr
The QC Analyst will analyze data for consistency, identify discrepancies, correct mistakes, and provide feedback and training to the operational teams to avoid future inconsistencies. This position ...
QC Analyst
$33.65 - $36.06/hr
QC Analyst Job Number: 26-01066 Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC. ECLARO's client is notable public research university. If you ...
QC Analyst
$33.65 - $36.06/hr
QC Analyst Job Number: 26-01066 Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC. ECLARO's client is notable public research university. If you ...
Quality Control Analyst
$20.25 - $27.25/hr
* Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ... the quality and quantity of the experience as it relates to the requirements of the position.
Quality Control Analyst
$20.25 - $27.25/hr
* Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ... the quality and quantity of the experience as it relates to the requirements of the position.
QC Analyst
Phoenix, AZ · Hybrid
$23.75 - $32/hr
The QC Analyst will analyze data for consistency, identify discrepancies, correct mistakes, and provide feedback and training to the operational teams to avoid future inconsistencies. This position ...
Quick apply
QC Analyst
Phoenix, AZ · Hybrid
$23.75 - $32/hr
The QC Analyst will analyze data for consistency, identify discrepancies, correct mistakes, and provide feedback and training to the operational teams to avoid future inconsistencies. This position ...
QC Analyst
$33.65 - $36.06/hr
QC Analyst Job Number: 26-01066 Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC. ECLARO's client is notable public research university. If you ...
QC Analyst
$33.65 - $36.06/hr
QC Analyst Job Number: 26-01066 Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC. ECLARO's client is notable public research university. If you ...
Quality Control Analyst
Wilson, NC · On-site
$20.25 - $27.25/hr
Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ... quality and quantity of the experience as it relates to the requirements of the position.
Quality Control Analyst
Wilson, NC · On-site
$20.25 - $27.25/hr
Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ... quality and quantity of the experience as it relates to the requirements of the position.
Quality Control Analyst
$20.25 - $27.25/hr
Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ... quality and quantity of the experience as it relates to the requirements of the position.
Quality Control Analyst
$20.25 - $27.25/hr
Performs a variety of chemical analyses and GMP review in accordance with cGMP, GLP, DEA and ... quality and quantity of the experience as it relates to the requirements of the position.
QC Analyst
Los Angeles, CA · Hybrid
$25.75 - $34.75/hr
Position Overview The QC Analyst is an analytical, process driven, and detail-oriented professional responsible for supporting Arixa Capital's data quality across the loan lifecycle. This role ...
QC Analyst
Los Angeles, CA · Hybrid
$25.75 - $34.75/hr
Position Overview The QC Analyst is an analytical, process driven, and detail-oriented professional responsible for supporting Arixa Capital's data quality across the loan lifecycle. This role ...
QC Analyst
Chapel Hill, NC · On-site
$33.65 - $36.06/hr
QC Analyst Job Number: 26-01066 Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC. ECLARO's client is notable public research university. If you ...
QC Analyst
Chapel Hill, NC · On-site
$33.65 - $36.06/hr
QC Analyst Job Number: 26-01066 Be at the forefront of innovation. ECLARO is looking for a QC Analyst for our client in Chapel Hill, NC. ECLARO's client is notable public research university. If you ...
Quality Control Analyst
Houston, TX · On-site
$23 - $30.75/hr
The QC Analyst will also support sample preparation, coordination, and data review for assays such as potency and other analytical methods. The QC Analyst is expected to demonstrate a foundational ...
Quality Control Analyst
Houston, TX · On-site
$23 - $30.75/hr
The QC Analyst will also support sample preparation, coordination, and data review for assays such as potency and other analytical methods. The QC Analyst is expected to demonstrate a foundational ...
Katalyst Jobs Information
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
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Job description
Job Summary:
- The CSV Engineer is responsible for ensuring that GxP computerized systems at the client site are validated in compliance with regulatory standards (21 CFR Part 11, EU Annex 11, GAMP 5).
- This role directly supports gene therapy manufacturing operations by leading validation activities for key systems, including Veeva QMS, BMRAM, analytical lab instruments, and the Metasys Client.
- By maintaining data integrity and system compliance, the CSV Engineer plays a critical part in ensuring product quality, patient safety, and regulatory inspection readiness.
- Author, review, and execute validation deliverables for GxP computerized systems, including Validation Plans, Requirements Specifications (URS/FS/DS), IQ/OQ/PQ protocols, Trace Matrices, and Validation Summary Reports.
- Support computer system validation efforts for Veeva Vault QMS, BMRAM (laboratory information management), analytical lab instruments (e.g., HPLC, UHPLC, PCR instruments, plate readers etc.), ERP System (NetSuite).
- Perform risk assessments to determine validation approach and ensure appropriate testing of system functionality, data integrity, and audit trail review.
- Manage system change control, deviations, and CAPAs related to validated systems, ensuring compliance with Forge's quality system.
- Collaborate with IT, QA, Lab Operations, and Facilities teams to support system upgrades, patches, and periodic reviews while maintaining a validated state.
- Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).
- 5-7+ years of experience in Computer System Validation (CSV) within a GxP regulated environment (pharmaceutical, biotech, or medical device).
- Working knowledge of GAMP 5, 21 CFR Part 11, EU Annex 11, and data integrity principles (ALCOA+).
- Experience validating at least one of the following: Veeva Vault QMS, BMRAM, laboratory instrumentation (e.g., Waters, Agilent, Chromeleon, Softmax or similar), or a building management system (Client) like Metasys.
- Strong technical writing skills and ability to execute protocols with minimal supervision.
- Nice to have: BMRAM and analytical lab instruments experience.