Quality Specialist

Company: Yoh
Location: San Diego
Posted on: November 19, 2023

Job Description:

Yoh Life Sciences is seeking a Quality Specialist to support our biotech -client in the -San Diego -Area. The initial focus of this position will be on document creation and control, driving adherence to basic QC processes, process improvements, and some manufacturing validation activities. - -Pay Rate: $40-$45/hr. Industry: -Biotechnology Location: San Diego - Duration: Initially a 4 month contract to start with the opportunity to extend depending on -the success of project -and workThe purpose of this position is to conduct and manage Quality Assurance External and Internal GMP Audits and to assure compliance with the GXP Audit Program. - The audits will be primarily focused on current Good Manufacturing Practices (GMP) but may include conformance to ISO standards where implemented. - The position will also be responsible for managing Quality Agreements and the Supplier/Vendor Qualification Program. Responsibilities -

• Maintain GXP audit program for external supplier audits.
• Perform GXP external audits per the Client's annual Master Audit Schedule.
• Prepare GXP external audit reports with details on audit scope and observations of non-compliance.
• Assist with regulatory inspections and partner audits.
• Conduct annual Mock Recalls for commercial products.
• Create and author Standard Operating Procedures (SOPs) as needed to support GXP external audits.
• Recommend corrective and preventive actions as needed to support compliance within the department.
• Manage and maintain the Quality Agreements.
• Manage and maintain the Supplier/Vendor Qualification Program -Qualifications
  • 1-3 years of relevant GMP Quality audit experience.
  • BS/BA degree in scientific discipline from an accredited college or university or equivalent experience preferred.
  • Strong knowledge of US and EU GMPs and their application.
  • Working knowledge of GCP and GLP regulations and requirements.
  • Ability to use Microsoft Word and Excel applications.
  • Ability to work proactively and cooperatively with managers and operational staff to solve quality problems.
  • Ability to manage multiple responsibilities with a high degree of self-motivation.
  • Good written, oral, and interpersonal English communication skills.
  • Understanding of Quality Agreements.
  • Knowledge of Supplier/Vendor compliance. -Note: Any pay ranges displayed are estimations. - Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. - All qualified applicants are welcome to apply.Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.Visit -to contact us if you are an individual with a disability and require accommodation in the application process.

Keywords: Yoh, San Diego , Quality Specialist, Other , San Diego, California