QA Specialist - II

OVERVIEW


We are currently searching for a skilled professional to join a well-known client’s team as a Quality Assurance Specialist II in Oceanside, CA. The Quality Assurance Specialist II will be responsible for executing a variety of quality activities to ensure compliance with regulatory requirements and internal quality standards in a GMP-regulated manufacturing environment. Their work will have a direct impact on product quality, compliance, and successful manufacturing operations, making this an excellent career opportunity.



RESPONSIBILITIES


•    Perform Quality Assurance activities supporting production, including batch record review, line clearance, and on-the-floor QA support 


•    Provide QA oversight and approval of Quality Control activities such as method transfers, Certificates of Analysis, and stability programs 


•    Approve product shipments and oversee packaging operations 


•    Ensure timely assessment, investigation, and closure of: 


    o    Deviations, discrepancies, CAPAs, and change controls 


    o    Laboratory investigations 


    o    Batch and material hold events 


•    Communicate lot disposition status and pending issues to management 


•    Provide real-time QA oversight on the manufacturing floor to ensure compliance with GMP standards 


•    Conduct walkthroughs and process observations to identify compliance risks 


•    Perform document control activities, including document archival and maintenance of training records 


•    Support regulatory inspections and audits 


•    Ensure products are manufactured in compliance with GMP and applicable regulatory guidelines (U.S. and EU) 


•    Escalate risks or issues that may impact product quality or release timelines 


•    Identify compliance gaps and partner with cross-functional teams to resolve them 


•    Author, review, and update SOPs, procedures, and forms as needed 


•    Perform additional duties as assigned 



EXPERIENCE


Minimum of 2 years of experience in Quality Assurance or related function within a GMP-regulated environment (or equivalent combination of education and experience)


Experience supporting manufacturing or production environments required


Background in Quality Control (Analytical, Virology, or Microbiology) preferred


Experience with investigations, deviations, CAPAs, and change controls required


Familiarity with regulatory inspections and audit support preferred


Experience with systems such as Veeva, Smartsheet, and LIMS highly desirable



EDUCATION


•    Master’s Degree in a biological science or related field OR 


•    Bachelor’s Degree with 2 years of relevant experience OR 


•    Associate’s Degree with 4 years of relevant experience OR 


•    High School Diploma with 5 years of relevant experience 



To be a best-fit your strengths must include:


•    Strong knowledge of GMP regulations and quality systems (U.S. and EU standards) 


•    Ability to work effectively in a fast-paced manufacturing environment with shifting priorities 


•    Excellent attention to detail and commitment to compliance and data integrity 


•    Strong problem-solving and risk identification skills 


•    Ability to collaborate cross-functionally and influence stakeholders 


•    Effective communication skills, both written and verbal 


•    Proficiency in Microsoft Office (Word, Excel, PowerPoint) and quality systems/tools 


•    Strong organizational skills with the ability to manage multiple priorities simultaneously


 

Full-time employees are also eligible for benefits options such as health coverage, life insurance, disability insurance, and 401k benefits.

At Advanced Group, our commitment to diversity and inclusion in every part of our organization is crucial to fulfilling our mission and demonstrating our REAL values. Advanced Group is committed to providing employment opportunities without regard to sex, race, color, age, national origin, religion, gender identity or expression, sexual orientation or sexual preference, pregnancy or maternity, genetic information, marital status, disability, veteran status, or any other basis protected by applicable federal, state or local law.

Advanced Group complies with federal and state disability laws and makes reasonable accommodations for applicants and candidates with disabilities. If a reasonable accommodation is needed to participate in the job application or interview process, please contact accommodationrequest@advancedgroup.com.


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