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Quality Control Specialist I

2 months ago

Hercules, United States Bio-Rad Laboratories, Inc. Full time

Employee will start the day by looking at the incoming Batch records (Purchase Orders) and utilize the QC/QA Priority list to schedule and determine which QC Functional testing will need to be completed. The QC group normally holds daily Tier 1 meetings from 9-9:15am and discuss any topics related to issues that are discovered during QC Inspection/testing, Production priority demands and any additional QC testing needed (In-line buffer testing, Patient Survey testing, Investigational testing due to QN’s, IFCC/NGSP certification testing). QC standards/controls  needed for functional testing will be prepared in the morning to be used throughout the day. Upon completion of QC lab testing, Employee will prepare the required SOP documents by documenting the raw data obtained on the forms, in excel sheets located in the QC monitoring folder on the shared drive and in the Unity Real Time application to assess any drift and will be turned into a lead/supervisor for review prior to submitting the batch records to QA. Employee may utilize the OOS process (Out of Specification) if Specs are not met during QC testing, which may or may not results in the initiation of a QN (Quality Notification). IF needed, the Employee may initiate changes in SOP’s and complete a Document Change order (DCO) and route the changes in the EtQc system. Clean up of the lab will be completed at the end of every business day and will also ensure that the Preventative Maintenance for any equipments are up to date

 

How You'll Make An Impact

  • Work with high collaboration and teamwork within the CPO group and other departments to help achieve business goals.
  • Champion the site's safety culture by following all safety policies while proactively identifying and reporting potential safety issues. Follow all procedures when handling chemicals to ensure all chemicals are disposed of according to regulations. Adhere to all safety protocols of the production process, especially on storing chemicals, recording information in SAP, operating machines, and disposing of materials, chemicals, and biologics. Ensures a clean and safe work environment.
  • Maintain a level of operational discipline while executing assigned tasks that are performed according to standard operating procedures. You may weigh, measure, prepare, mix, monitor, and adjust chemical materials while operating large-scale reactors and other equipment used to produce life science research products. Collect samples of chemical solutions prepared and perform in-line product testing to resolve simple chemical issues before completing the production process.
  • Maintain a thorough understanding of required policies, procedures, quality standards, good manufacturing practices, and safety environmental regulations through the development and demonstration of excellent documentation skills as required by local, federal, and company regulations.
  • Perform equipment cleaning and batch preparation, including communication with maintenance. Communicates inventory, planning, and quality issues to supervisor or appropriate department partner.

What You Bring:

  • Bachelor's degree or equivalent in a life science (Chemistry, Biology) or related field.
  • Advanced degree preferred.
  • 0-2 years in a general laboratory environment performing analyses in the areas of chemistry, biochemistry, or associated areas of life sciences, or equivalent combination of education and experience.
  • Understands and can apply GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices).
  • Strong computer skills.
  • Experience with ERP systems a plus, SAP preferred.

Compensation: The estimated hourly range for this position is $32.00 to 36.00 per hour at the time of posting.  Actual compensation will be provided in writing at the time of offer, if applicable, and is based on several factors we believe fairly and accurately impact compensation, including geographic location, experience, knowledge, skills, abilities, and other job permitted factors.  As a temporary associate, your employment will be managed directly through our approved agency provider.​

 

Who We Are: For 70 years, Bio-Rad has focused on advancing the discovery process and transforming the fields of science and healthcare. As one of the top five life science companies, we are a global leader in developing, manufacturing, and marketing a broad range of high-quality research and clinical diagnostic products. We help people everywhere live longer, healthier lives. Recently voted a Best Place to Work, Bio-Rad offers a unique employee experience with collaborative teams that span the globe. Here, you are supported by leadership to build your career and are empowered to drive change that makes an impact you can see.

 

EEO Statement: Bio-Rad is an Equal Employment Opportunity/Affirmative Action employer, and we welcome candidates of all backgrounds. Veterans, people with physical or mental disabilities, and people of all race, color, sex, sexual orientation, gender identity, religion, national origin and citizenship status are encouraged to apply.

 

Agency Non-Solicitation:  Bio-Rad does not accept agency resumes, unless the agency has been authorized by a Bio-Rad Recruiting Representative. Please do not submit resumes unless authorized to do so. Bio-Rad will not pay for any fees related to unsolicited resumes.

 

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