Ideal candidate:

• Primary responsibility is proving quality oversight on the manufacturing floor.
• We are seeking candidates with QA experience in a biopharmaceutical GMP manufacturing environment who can hit the ground running and integrate quickly into our 24/5 operation.
• Ideal candidates will have a strong understanding of aseptic techniques, gowning procedures, electronic batch record review, and presence inspection support.
• Experience in Quality Assurance for Manufacturing, Flexible Working Schedule, Team Player and Detail Oriented.

Duties include but are not limited to:

• Purposeful presence on the manufacturing floor, inc. Inspection support, ASP and QA assessments,
• Electronic batch record review,
• SOP revision approval,
• Maximo System - Work order, job plan approvals,
• Quality support and approval of minor deviations and CAPA records.
  MES revisions and approvals
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area quality for the Drug Product Quality Assurance department in the execution of projects necessary to achieve departmental operational goals and will work in a team matrix environment.
  
  Preferred Qualifications:
• Bachelor’s Degree in Biochemistry, Biology, Chemistry, or related science field
• Demonstrated ability to perform GMP operations including following detailed SOPs, maintaining training, and good documentation practices
  Experience managing projects through to completion meeting timelines.
  Ability to evaluate documentation and operations according to company procedures.
• Experience working with Quality Systems
  Strong organizational skills and ability to manage multiple tasks at one time
• Effective communication skills (both written and verbal)
• Demonstrated ability to work as both a team player and independently
  Display leadership attributes and drive improvement initiatives
• Solid understanding and application of aseptic behaviors and principles

 Pay Range - $35 - $37/hr