To discuss more about this job opportunity, please reach out to Chitrank Rastogi (LinkedIn URL - https://www.linkedin.com/in/chitrank-rastogi-55119a102/), email your updated resume at Email - chitrank.rastogi@collabera.com or give me a call at (425) 523-1648. Thank you!

Pay Range - $30 to $33/hr. (negotiable)

Job Description:
Job Roles & Responsibilities:

• This position supports our Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Substance manufacturing areas.
• Under general supervision, the role provides support and compliance oversight to Manufacturing and Facilities & Engineering areas/staff in the execution of their processes, procedures, and use of quality systems.
• Duties include purposeful presence on the floor, electronic batch record review, SOP revision & approval, work order approval, and quality approval of minor deviations and CAPA records.
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
• The Sr. Associate will also represent a functional area for the Drug Substance 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.
• Also, the ability to make Quality-based decisions to ensure compliance.
• Experience managing projects through to completion & meeting timelines.
• Evaluating 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.

Basic Qualifications:        

• Master's degree OR Bachelor's degree and 2 years of experience OR Associate degree and 6 years of experience OR High school diploma / GED and 8 years of experience

Top 3 Must Have Skill Sets:        

• Experience working with Quality Systems / QA
• Batch Record Experience
• Plant Quality Assurance provides quality oversight to manufacturing
• Looking for someone who can work cross-functionally amongst many different teams and be comfortable with shifting priorities as the business needs change.

Day to Day Responsibilities:      

• Duties include electronic batch record review, batch record review, SOP and MP revision approval, work order approval, and quality approval of non-conformances and CAPAs.
• Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion.
• The incumbent will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals and will work in a team matrix environment.