QA Specialist

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 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. By applying and submitting your resume, you authorize Yoh to review and reformat your resume to meet Yoh’s hiring clients’ preferences. To learn more about Yoh’s privacy practices, please see our Candidate Privacy Notice: Stay Safe During Your Job Search Fraudulent recruiting communications have become increasingly common. Emails from Yoh recruiters will only come from an @yoh.com email address. Yoh will never ask candidates to pay fees, purchase equipment, send gift cards, or transfer funds as part of the recruiting or hiring process. If you receive a communication that appears suspicious or requests payment, contact Yoh directly before responding or sharing personal information. #J-18808-Ljbffr