Job Description

QA SPECIALIST - SIMPLY BIOTECH

OVERVIEW

Are you looking for a new career opportunity with an exciting biotech company?! Then we have got the right team for you! In this role, you are responsible for the duties listed below.

Immediate opening for a QA Specialist in New Brunswick, NJ who possesses:

• Bachelor's degree
• 1. Bachelor’s degree

   

• 2+ years of experience within biotech 
• 2+ years of experience with deviations, investigations, customer complaints, supplier issues
• 2+ years of experience supporting FDA audits and customer audits
• QC experience preferred

Email resumes to acannon@simplybiotech.com or call 858.227.4596

FULL DESCRIPTION: ASSIST CUSTOMERS WITH VARIOUS QUALITY DOCUMENTATION REQUESTS REGARDING THE COMPANY'S QUALITY MANAGEMENT SYSTEM. ASSIST SALES TEAM BY PROVIDING QUALITY-RELATED DOCUMENTATION AS REQUESTED. ASSIST IN ASSURING THAT THE COMPANY OPERATES IN ACCORDANCE TO CURRENT GOOD MANUFACTURING PRACTICES & REGULATIONS AND IN COMPLIANCE TO ISO 9001:2015 QUALITY STANDARDS.

The selected candidate will further possess:

• Knowledge of Quality System requirements of ISO 9001:2015, current Good Manufacturing Practices 21 CFR 210& 211, IPEC PQG, and ICH Q7/A.
• Must have basic computer literacy including familiarity of programs such as Word, Excel and Pagemaker, Filemaker.
• Lean process improvement and Six Sigma, 5 S experience and background preferred
• Must have strong oral and written communication skills and be able to manage multiple tasks.
• Ability to read, analyze and interpret common scientific and technical journals, financial reports, and legal documents.
• Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community.
• Ability to effectively present information to top management, public groups, and/or members of senior management.
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.
• Ability to write reports, business correspondence, and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the public.
• Ability to calculate proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
• Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form.
• Ability to deal with problems involving several concrete variables in standardized situations.

The selected candidate will be responsible for the following:

• Complete Customer Quality Surveys & Questionnaires
• Coordinate Quality / Technical data requests: such as Customer Spec Sheets, or Certificates of Origin, Stability Data, GMP Certifications, etc.
• Perform Internal Quality Audits
• Assist in hosting Customer Quality System Audits and or Regulatory Inspections
• Maintain and continual development of Scientific Documentation/Quality Response Package Maintain Supplier Qualification Program
  1. Evaluating supplier self-audit questionnaire
  2. Performing site quality system audits
  3. Tracking supplier performance
  4. Responsible for Supplier Corrective Action Request (SCAR)
  5. Establishment of Quality Agreements/Clauses
  6. Supply chain resolution
  7. Maintain and monitor CofA challenge
• Maintain Customer Change Control Program and Notification Support to affected parties
• Assist with quality investigations

For immediate and confidential consideration, please email your resumes to acannon@simplybiotech.com or call 858.227.4596

More information can be found at www.simplybiotech.com