Stability Analyst

Stability Analyst
  • $25 - $32 per Hour
    HOUR
  • Temporary
  • Hayward CA, US Hayward ALAMEDA US 94545
Job Ref: JO000114439
Sector: Clinical
Sub-sector: Quality
Date Added: 22 March 2021


JOB TITLE

The Stability Analyst II supports the Stability department by performing chemical, and physical analysis for bulk drug substance and special project samples. The Stability Analyst II will also support the department by assisting in qualification, validations and review of quality records such as local documents, deviations, CAPAs and change records.

EXPERIENCE REQUIRED: PHARMA/BIOTECH - GMP/LAB EXPERIENCE

Job Description Summary

The Stability Analyst II supports the Stability department by performing chemical, and physical analysis for bulk drug substance and special project samples. The Stability Analyst II will also support the department by assisting in qualification, validations and review of quality records such as local documents, deviations, CAPAs and change records.

Job Description*

• Conduct biological, chemical and physical analyses on GMP and Pilot batches requiring stability testing. Work under some supervision.

• Support and potentially lead continuous improvement projects in the Stability Laboratory such as 6S, Kaizen, Just-do-it's, and VIP.

• Serve as Mentor to Stability Analyst I positions. Provide training and work direction for Stability Analyst I positions as required.

• Perform review of test data, which includes overall documentation practices. Perform release functions in LIMS or other computerized systems.

• Use sophisticated laboratory instrumentation and computer systems to collect and record data.

• Perform advanced biological and chemical assays requiring precise analytical skills and understanding of biology and chemistry principles.

• Complete all testing, including special project / protocol testing in a timely and appropriate manner.

• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations.

• Investigate deviations and write non-conformance and lab investigation reports.

• Participate in functions involving teams, which impact production, increase efficiency, solve problems, generate cost savings and improve quality.

• Perform laboratory and manufacturing audits as required. Audit and update, as required, plant SOPs.

• Perform equipment maintenance and calibrations as required.

• Support execution of validations for lab equipment, lab methods, or facility projects.

• May be required to generate, execute, and summarize special laboratory studies.

• Drive Lean principles such as 6S throughout daily work activities.

• Ensure personal training requirements are met and that training records are current.

• Demonstrates an ability and desire to learn from experience • Treats errors as a learning opportunity • Is willing to take on new challenges • Takes steps to adapt thinking and behavior to support change • Supports a culture of process improvement and problem solving • Demonstrates an openness to trying new approaches

• Seeks to understand the corporate strategy and how his/her business area contributes to the company’s success • Understands the impact of his/her own actions on his/her business area • Expresses ideas that will improve his/her business area • Uses knowledge of his/her business area to make accurate and timely decisions

• Works as an active member of his/her team • Generously shares information and knowledge with others on team • Demonstrates an openness to different perspectives by balancing listening and speaking • Treats all co-workers and customers professionally and with respect

SRG is an Equal Opportunity Employer - All qualified applicants will receive consideration without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law.

SRGTalent
21/04/2021 12:00:00
USD 25.00 32.00 Hour
Contact Consultant:
Jennifer Law

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