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!

Job Description:
Job Roles & Responsibilities:

• QA Sr. Associate will be responsible for Quality On the Floor in support of Manufacturing activities.
• This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate batch record and attachment reviews, logbook reviews, area changeover reviews, real-time decision-making regarding quality requirements.
• This is a unique opportunity to foster a strong partnership and learning environment between Manufacturing and Quality staff.
• Team player, and good communicator. Willing to support additional workload by checking with team members, good communication with the team members on a daily basis of what needs to be prioritized and what has been completed, and understanding of when to escalate events to me.

When reviewing resumes, what stands out to you when looking for the right applicants?

• Academic background in Sciences, and experience working in Quality Assurance in either Biotech or Pharmaceutical industry.

What is your minimum education and experience requirements as well as the maximum education/experience requirement you think it suitable for this role?

• Master’s degree OR Bachelor’s degree and 2 years of experience (in QA or MFG) OR Associate’s degree and 6 years of experience (in QA or MFG).

Day to Day Responsibilities:

• Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP) and other applicable regulations.
• Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
• Performs review and approval of cGMP processes, procedures, documents and records.
• Ensure that changes that could potentially impact product quality are assessed according to procedures.
• Review executed batch records, attachments, and area logbooks.
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
• Alert senior management of quality, compliance, supply and safety risks.
• Complete required assigned training to permit execution of required tasks.