Job Description

Lead Quality Assurance Officer - Los Angeles

Location:

WestwoodCalifornia

Date Posted:

9/8/2022

Employment Type:

Consulting

Recruiter:

John Kang

Recruiter Email:

john.kang@avidtr.com

Job ID:

JN -082022-15186

Job Description

AVID Technical Resources is seeking an experienced Lead Quality Assurance Officer to support our Health Care Client onsite in Los Angeles

DUTIES AND TASKS
80%

As GMP Quality Assurance Officer, responsible for...
  1. The day-to-day GMP quality assurance compliance activities including:
    • Management of OOS, deviations, CAPA and change control documents
    • Releasing reagents per established procedures
    • Establishing quality standards relating to QA/QC to ensure that the organization meets applicable State, Federal and accrediting agency regulatory requirements
    • Actively monitoring changes in the Federal regulations and other accrediting agencies’ standards to ensure continued compliance with current regulations and standards
    • Maintaining core competencies as a Quality Assurance Inspector.  
  2. Writing, review and approval of Master Production (batch) Records, Standard Operating Procedures (SOPs), worksheets, forms, Specifications, Validation Protocols and reports, and Production Record Control systems to ensure compliance
  3. Evaluating and interpreting regulations and standards to determine applicability and for effectively communicating such applicability
  4. Performing routine audits and inspections to ensure compliance and provide written reports of such, ensuring appropriate responses and follow up
  5. Ensuring issues of critical non-compliance are handled in an appropriate and timely manner. 
  6. Maintaining a document management program for all forms, policies and procedures, SOPs for the HGCTF
  7. Review and analyze data; summarize reports
  8. Track and trend quality indicators for the HGCTF
  9. Prepare, maintain and update technical protocols, manuals, worksheets, forms, SOPs and all such documents for the HGCTF
  10. Responsible for the completion of special projects and duties as assigned
  11. This position requires a high level of confidentiality and discretion
20%
 The Lead QA Officer is responsible for...
  1. supervising, training and providing guidance to other QA officers in day-to-day GMP activities and work requiring critical decision making to ensure compliance
  2. Conducting employee reviews and evaluations and performs training and disciplinary action
  3. Staff training, and preparation of training material.  

 SKILLS, KNOWLEDGE AND ABILITIES 
  • Bachelor of Science Degree or  Master's degree in Biology, Chemistry, or related field and a minimum of five years of GMP quality assurance experience, a higher degree (Ph.D. or Pharm D.) with knowledge about GMP QA. 
  • Previous experience directly involved with federal regulations regarding GLP and GMP.
  • Demonstrated skill in gathering pertinent data, preparing narrative reports, statistical reports, charts, graphs, and tables. 
  • Demonstrated ability to carry out analytical tasks, to identify and define issues and alternatives, to resolve problems, and to draw logical conclusions. 
  • Demonstrated skill in reviewing data and material compiled by others for completeness and accruacy to ensure that incorrect/incomplete data is corrected.   
  • Strong interpersonal communication skills to effectively and diplomatically interact with  physicians, staff, administration & sponsors. 
  • Ability to deal with and maintain confidential and sensitive information with discretion.  Ability to determine what information is confidential and to protect the confidentiality of that information. 
  • Demonstrated skill in good decision making and taking appropriate action in situations where no established criteria exists or where answers to problems are not readily available. Ability to work on a diverse variety of projects simultaneously, organize multiple projects for efficiency and cost-effectiveness. 
  • Demonstrated skill in prioritizing workflow to meet deadlines, often under pressure of conflicting demands, while maintaining accuracy and effectiveness of work. 
  • On occasion, ability to work flexible hours. Ability to attend off-site staff meetings, conferences and investigator meetings. 
  • Strong oral and written communication skills. 
  • Exceptional database and computing skills.  
  • Excellent English-writing skills to compose, proofread correspondence and written reports for conciseness, clarity, appropriate grammar, correct spelling, and proper punctuation. Ability to write concise and accurate administrative reports, policies, procedures, and correspondence. 
  • Working knowledge of some medical and scientific terminology for protocol abstracting and conversation with research personnel. 
  • Demonstrated skill in records management.  Skill in establishing and maintaining complex filing systems. 
  • Demonstrated skills with personal computers, spreadsheets, databases and word processing applications for the maintenance of administrative records, analysis of data, and the preparation of reports. 
  • Demonstrated skill in utilizing programs such as Word, Excel, and other database software.  Ability to learn other systems/software as required. 
  • Demonstrated knowledge of FDA Good Laboratory Practice, Good Tissue Practice and Good Manufacturing Practice guidelines. 
  • Demonstrated ability to develop and monitor quality improvement plans and SOPs. Teamwork skills as well as the ability to prioritize and demonstrate critical thinking. Demonstrated ability to work independently and collaboratively with multiple departments while utilizing innovation to elicit compliance. 
 
About AVID Technical Resources:
AVID (Applications, Voice, Internet, Data) Technical Resources is a contract and permanent IT recruiting company. Headquartered in Boston with 9 offices around the US, AVID specializes in placing information technology professionals with either an Infrastructure Support or Applications Development background.
Since our inception in 2003, AVID has grown to be among the leading IT recruiting firms in the area.  This explosive growth has led to a number of awards and recognition.  Inc. Magazine listed AVID three times on their exclusive Inc. 500/5000 Fastest Growing Privately-Held Companies in the US.  AVID was named one of the Leading IT Staffing Agencies in the Northeast by Forbes Magazine and the Boston Business Journal ranked AVID Technical Resources the 7th Fastest Growing Privately-held Company in Massachusetts. AVID Technical Resources has not only been recognized by local and national business and staffing organizations, but also by its most important critics: our clients and candidates. Check out our reviews on Glassdoor, Indeed, and Google here
Contact one of our IT recruiters today: www.avidtr.com.
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