Laboratory Qc Analyst

Job Title: Stability Analyst (QC Team)

Location: Rocklin, CA

Hours: 8:00am - 5:00pm

Job Type: Contract, with potential to be hired on

Job Description:

Under moderate supervision, the Stability Analyst will be part of the Quality team and responsible for performing stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements. Support the day-to-day activities of the Quality department while adhering to applicable regulatory requirements, ISO 13485, local and global QMS.

Essential Duties and Responsibilities:
- Perform stability testing of IVD and ASR products according to SOPs and in compliance with local and global QMS and regulatory requirements.
- Record and document testing results accurately and per applicable regulatory and SOP requirements.
- Data analysis using Microsoft Excel.
- Maintain extensive knowledge of Standard Operating Procedures and GMP regulations and guidelines.
- Troubleshoot equipment problems.
- Recognize atypical and out of specification results, instrument malfunctions, and methodology issues and participate in the investigation process.
- Maintain cGMP compliance in the laboratory.
- Other duties as assigned or required

Additional Responsibilities:
- Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management
- Must be willing and able to work on weekends or extended hours as needed

EDUCATION & EXPERIENCE:
B.S. degree in a biological science or equivalent life sciences degree preferred, or equivalent combination of education and experience
Experience in medical device, drug, and/or biologics
General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards

KNOWLEDGE, SKILLS & ABILITIES:
- Knowledge & experience in ELISA, bioburden and IHC testing
- Ability to work independently and manage multiple analyses
- Knowledge of cGMPs related to QC operations
- Experience working in ISO 13485 and/or FDA regulated laboratory
- Experience in SAP and/or SAP NEXT
- Good computer skills, PC including MS Excel
Excellent written and verbal skills```Duties```
- Conduct quality inspections and audits to ensure compliance with FDA regulations and company quality standards.
- Perform quality control checks on incoming materials, in-process production, and finished products.
- Utilize various measuring tools such as calipers and micrometers to verify product dimensions.
- Collect and analyze data to identify trends and areas for improvement in quality systems.
- Collaborate with cross-functional teams to address quality issues and implement corrective actions.
- Maintain accurate documentation of quality inspections, test results, and corrective actions taken.

- Excellent attention to detail and ability to identify deviations from quality standards.
- Strong analytical skills for data collection and analysis.
- Effective communication skills to collaborate with cross-functional teams.

MilliporeSigma is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.

Job Types: Full-time, Contract

Pay: $27.00 - $28.00 per hour

Benefits:

• Dental insurance
• Health insurance
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Work setting:

• In-person

Application Question(s):

• Are you local to the Rocklin, CA area?

Education:

• Bachelor's (Preferred)

Experience:

• Immunohistochemistry: 2 years (Preferred)
• PH Testing: 2 years (Preferred)
• ISO 13485: 2 years (Preferred)
• Stability Testing of IVD: 2 years (Preferred)
• ASR: 2 years (Preferred)
• Quality control: 2 years (Preferred)
• Stability: 3 years (Preferred)

Language:

• English (Required)

Work Location: In person