QA Specialist

Yoh,-A-Day-; Carlsbad (CA); On-site; USD 41,000 - 59,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

Health Savings Account (HSA)

Life & Disability Insurance

MetLife Voluntary Benefits

Employee Assistance Program (EAP)

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Job summary

Yoh Life Sciences is hiring a QA Specialist in North County San Diego (Carlsbad area) on a contract-to-hire basis. Compensation ranges from $35 to $43 per hour, with a schedule of 8am to 4:30pm. The role focuses on documentation management, training, and quality system processes to ensure FDA QMSR and ISO compliance.

The ideal candidate will have a scientific degree, at least 3 years in QA, and familiarity with cGMP and GDP. Start date is ASAP. Location is Carlsbad, CA.

Qualifications

• Bachelor’s degree in a scientific discipline or Associate’s degree in a scientific discipline with relevant experience.
• Minimum of 3 years of QA work experience.
• Quality Assurance experience in a cGMP and/or manufacturing environment
• Working knowledge of FDA QMSR, ISO 9001, ISO 13485, ISO 14971
• Experience with GDP

Responsibilities

• Maintain Document Control and Training Management Systems in compliance with internal procedures and applicable global regulations.
• Ensure products meet quality standards and regulatory requirements.
• Review, approve, and release batch records per procedures and acceptance criteria.
• Generate certificates of compliance and supporting documentation for shipments.
• Perform verification and effectiveness checks for CAPAs, deviations, and nonconformance reports; document objective evidence.
• Schedule and conduct monthly lab walk-throughs and annual internal audits with action reports.
• Collaborate cross-functionally to identify root causes and support corrective actions.
• Complete customer and vendor quality questionnaires.
• Support Management Review meetings with quality metrics and trends.
• Maintain QMS subsystems (CAPAs, NCRs, Customer Complaints, Doc Control, Equipment/Facilities, Supplier qualification)

Skills

Documentation management

Training management

Regulatory compliance

cGMP knowledge

GDP knowledge

Education

Bachelor’s degree in a scientific discipline

Associate’s degree in a scientific discipline with relevant experience

Job description

Yoh Life Sciences is hiring for a QA Specialist, for our diagnostics customer in North County San Diego. The QA Specialist will be ensuring effective management of documentation, training, and quality system processes in compliance with FDA quality system regulations and applicable ISO standards.

Pay Rate: $35-$43/hr Schedule: 8am - 4:30pm Location: Carlsbad Duration: contract-to-hire Start Date: ASAP.

Responsibilities

• Under the direction of the Senior Quality Systems Manager, this position is responsible for maintaining Document Control and Training Management Systems in compliance with internal procedures and applicable global regulations.
• Ensure products or services meet quality standards and regulatory requirements.
• Review, approve, and release batch records in accordance with approved procedures and documented acceptance criteria within defined timelines.
• Generate certificates of compliance, information sheets, manufacturing declarations and USDSA APHIS documentation for outgoing shipments.
• Perform verification and effectiveness checks for CAPAs, deviations, and nonconformance reports, including documentation of objective evidence to support effectiveness and formal closure.
• Demonstrate working knowledge of cGMP and GDP by independently scheduling and conducting monthly laboratory walk-throughs and annual internal audits based on an approved audit schedule, with documented action reports and follow-up tracking.
• Collaborate cross-functionally to identify documented root causes using appropriate analytical methods and support corrective and preventive actions.
• Complete customer and vendor quality questionnaires.
• Support Management Review meetings by preparing and presenting quality metrics, trends, and performance data to support management review inputs and documented outputs.
• Maintain and manage Quality Management System (QMS) subsystems in accordance with regulatory and standard requirements, including: CAPAs, NCRs, Customer Complaints, Doc Control, Equipment and Facilities support, and Supplier qualificationand management.

Qualifications

• Bachelor’s degree in a scientific discipline or Associate’s degree in a scientific discipline with relevant experience.
• Minimum of 3 years of QA work experience.
• Quality Assurance experience in a cGMP and/or manufacturing environment
• Working knowledge of FDA QMSR, ISO 9001, ISO 13485, ISO 14971
• Experience with GDP

Estimated Min Rate: $30.10

Estimated Max Rate: $43.00

Benefits

Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly epayroll
• Referral Bonus Programs
• Certification and training opportunities

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.

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 https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

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