Location: San Diego
Posted on: November 19, 2023
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
- 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
- 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
- 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
- Good written, oral, and interpersonal English communication
- 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
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