QA Specialist

American Society for Quality; Carlsbad, Northern (CA, KY); Hybrid; USD 41,000 - 59,000; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision

401K Retirement Savings Plan

Direct Deposit & weekly epayroll

Referral Bonus Programs

Certification and training

Job summary

Yoh Life Sciences in Carlsbad, CA is seeking a QA Specialist to oversee documentation management, training, and QMS processes in alignment with FDA QMSR and ISO standards. You will review batch records, generate certificates, and support CAPA and audits in a cGMP environment.

The role demands 3+ years QA experience, a scientific degree, and the ability to collaborate cross-functionally. This contract-to-hire position offers competitive pay and benefits through Yoh’s extensive network.

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 global regulations.
• Ensure products or services meet quality standards and regulatory requirements.
• Review, approve, and release batch records in accordance with procedures and acceptance criteria.
• Generate certificates of compliance, information sheets, manufacturing declarations and USDSA APHIS documentation for shipments.
• Perform verification and effectiveness checks for CAPAs, deviations, and nonconformance reports.
• Demonstrate knowledge of cGMP and GDP via monthly audits.
• 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 including CAPAs, NCRs, complaints, doc control, equipment, facilities, and supplier qualification

Skills

Documentation management

Quality oversight

Education

Bachelor’s degree in a scientific discipline

Associate’s degree in a scientific discipline with relevant experience

Tools

FDA QMSR

ISO 9001

ISO 13485

GDP

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

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

What’s In It for You?

We welcome you to be a part of the largest and legendary global staffing companies to meet your career aspirations. Yoh’s network of client companies has been employing professionals like you for over 65 years in the U.S., UK and Canada. Join Yoh’s extensive talent community that will provide you with access to Yoh’s vast network of opportunities and gain access to this exclusive opportunity available to you. Benefit eligibility is in accordance with applicable laws and client requirements. 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. 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 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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