Quality Assurance Associate

Title: Quality Assurance Associate

Reports to: Quality Assurance Supervisor or Manager

Department: Quality

Responsibilities:

• Conducts Annual Drug (Product) Reviews and Device History Reviews.

• Maintains Regulatory Compliance documents and documents of external origin.
• Maintain Document Control (including Records Retention)
• Participates in internal and external audit process.
• Participates in Mock (product) recall audits.
• Maintain SOPs and Quality Forms as part of Document Control.
• Maintains records of customer-approvals documents as evidence of authenticity.
• Participate in QA Audits and draft reports of such audits.
• Effects changes to specification sheets as approved through change control requests.
• Support Change Control program and maintain evidence of product and process changes.
...

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

CSBio is seeking an experienced Quality Assurance Associate Manager to provide oversight in Quality Systems, API operations and validation activities including facilities, equipment, utilities, systems, process,...

CSBio is a peptide contract manufacturing founded in 1993. Our initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, we opened our custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, we opened our peptide production facility in Menlo Park, CA and in 2014, we expanded our production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, we passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, we added additional cGMP clinical production capacity in Milpitas, CA.

Job Duties:

• Host and provide responses to client audits and regulatory inspections.
• Oversee Quality Management System at CSBio encompassing quality investigations including...

The Quality Assurance Associate works under the guidance of the Director of Quality Assurance in completing customer surveys and documentation, researching international food regulations, as well as performing laboratory functions consisting of the collection, sampling and testing of products using aseptic techniques; assurance on maintaining process control and product safety. This position operates within FDA, FSMA and Global Food Safety Initiative (GFSI) requirements defining food safety standards for the safe production of food in the plant and offices i.e. within the standards of defined risk levels by area

1st shift: 8:00 AM -4:00 PM, M-F

Pay: $22.00, $1.00 raise upon hire on to company

Job type: temp to hire

Job location: Racine, WI 53403

Overall Functions

1. Cross train in all QA functions in order to provide coverage of QA positions in the event of absences.

2. Perform QA functions as needed, including FSMA and SQF...

Who We Are

Alene Candles LLC & Midwest is a private label, contract manufacturer that produces high-quality candles for some of the world’s most recognized retail, boutique, and cosmetic brands. With our headquarters in New Hampshire and additional locations in Ohio, we’ve been in business for over 25 years. We are passionate about making the best products in the world, making safety our number one priority, and being an insanely great place to work. We were proudly named Best Company to Work For in 2020 and 2021 and Business of the Year in 2023.

The Position

We are seeking a Quality Assurance Compliance Associate to be responsible for overseeing quality compliance activities across multiple manufacturing...

Who We Are

Alene Candles LLC & Midwest is a private label, contract manufacturer that produces high-quality candles for some of the world’s most recognized retail, boutique, and cosmetic brands. With our headquarters in New Hampshire and additional locations in Ohio, we’ve been in business for over 25 years. We are passionate about making the best products in the world, making safety our number one priority, and being an insanely great place to work. We were proudly named Best Company to Work For in 2020 and 2021 and Business of the Year in 2023.

The Position

We are seeking a Quality Assurance Compliance Associate to be responsible for overseeing quality compliance activities across multiple manufacturing...

Reports to: Quality Assurance Supervisor or Manager

Responsibilities:

• Conducts Annual Drug (Product) Reviews and Device History Reviews.

• Maintains Regulatory Compliance documents and documents of external origin.
• Maintain Document Control (including Records Retention)
• Participates in internal and external audit process.
• Participates in Mock (product) recall audits.
• Maintain SOPs and Quality Forms as part of Document Control.
• Maintains records of customer-approvals documents as evidence of authenticity.
• Participate in QA Audits and draft reports of such audits.
• Effects changes to specification sheets as approved through change control requests.
• Support Change Control program and maintain evidence of product and process changes.
• Maintains SOP binders and updates such documents through approved CCs.
• Supports EWL Employee...

• Provides support for implementation, troubleshooting and maintenance of IT systems.
• Provides support for hardware problems and remains involved in the resolution process.
• Configures and manages LINUX operating system and installs.
• Creates bash shell scripts to aid in system stability and deployment repeatability.
• Manages the daily activities of configuration and operation of IT systems.
• Provides Tier 1 (Help Desk) problem identification, diagnosis and resolution of problems.
• Optimizes system operations and resource utilization, and performs system capacity analysis and planning.
• Provides detailed analysis and feedback to management and customers for escalated tickets.
• Loads operating system software, troubleshoots, maintains integrity and configures network components.

Requirements

TS/SCI with poly required

• Four (4) years experience in projects of similar...

Navarro Research and Engineering is recruiting for a Quality Assurance Associate Engineer II in Richland, WA.

Navarro Research & Engineering is an award-winning federal contractor dedicated to partnering with clients to advance clean energy and deliver effective solutions for complex challenges in the nuclear and environmental fields. Joining Navarro means being a part of an exceptional team committed to quality and safety while also looking for innovative strategies to create value for the client’s success. Headquartered in Oak Ridge, Tennessee, Navarro has active programs in place across the nation for DOE/NNSA, NASA, and the Department of Defense.

This position will support Navarro-ATL. Navarro-ATL is located in Richland, WA, and operates, manages, and maintains the 222-S Laboratory Complex for the Department of Energy. The Navarro-ATL members are Navarro Research and Engineering, Inc. (Oak Ridge, TN), and Advanced Technologies and Laboratories International...

Global Life Science Hub has taken on a fascinating, exclusive retained assignment with a rapidly growing life science organisation that provides unique lab services to a vast range of pharma's, from start-ups to top 10. They are looking to further appoint 230 new allocated positions across the United States in the next 24 months.

Due to this exciting growth stage, they’re now searching for a brand-new seasoned Quality Assurance Manager/Director that will be responsible for assisting the Vice President with ensuring quality processes are maintained. The appointed candidate will also be liable to act as the chief internal regulatory advisor in the Senior Director’s absence and will drive growth in the US and Europe.
Responsibilities

• Leads and directs activities of the Quality and Regulatory Services department
• Performs routine assessment of QRS team members and develops team development plans
• Assesses and responds to issues...

Attention Quality Enthusiasts! Join Our Trading Card Company as a Quality Assurance Tech!

Are you passionate about ensuring every detail is perfect? Do you have a keen eye for spotting imperfections? Our leading trading card company is looking for a meticulous Quality Assurance Tech to join our team!

Job Title: Quality Assurance Associate

Company Overview: OnIt Athlete, a dynamic and innovative fully licensed NIL collegiate trading card company, is seeking a detail-oriented and highly motivated individual to join our team as a Quality Assurance Associate. With a commitment to excellence and a customer-centric approach, we are dedicated to providing top-notch trading cards and memorabilia to our clients. OnIt Athlete is on track to work with over 65 Universities and 215 teams in 2024. In 2024, OnIt Athlete is on track to pay student athletes over $5 million.

Position: Quality Assurance...