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 San Diego, CA who possesses:

• Bachelor's degree is required
• 5+ years of QA experience in the biopharma industry (CMO/CDMO is a plus)

Email resumes to akubota@simplybiotech.com or call 858.239.2851

_FULL DESCRIPTION: _

The selected candidate will be responsible for the following:

• Participate and contribute through team functions such as supplier audits, assist with customer audits, annual product review, change control, CAPA, complaint handling, document control systems, environmental monitoring, EM reports, and cGMP training of employees. 
• Back up activities of Quality Assurance Specialist (Operations) which includes working on deviations, batch record review, clinical and commercial product release. 
• Enter data into databases in accurate and timely manner.
• Ensure Quality System, cGMP and ICH guidelines are followed on site. Help with annual analysis of upgrades to Quality System in terms of both Operations efficiency as well as new FDA or ICH regulatory changes.
• Partner with Regulatory Affairs, Manufacturing, Development, Marketing as well as Corporate
• Quality on customer projects, regulatory submissions, and harmonization of PPL Group's Global
• Quality standards across PPL Group sites.
• Maintain our successful track record with FDA and other regulatory agencies.
• Perform other tasks as assigned.

For immediate and confidential consideration, please email your resumes to akubota@simplybiotech.com or call 858.239.2851

More information can be found at www.simplybiotech.com

Company Description

IT'S ALL WE DO. We believe that effective and successful recruiting must be specialized, both in industry and geography. It is the only way to truly know both companies and job seekers and the most effective way to bring them together. THE INSIDER'S NETWORK When you register with us, we plug you into an existing network of companies that don’t always post to job boards. You will have access to unique opportunities throughout the greater Los Angeles area - opportunities you won’t find on your own. THANK YOU FOR CALLING We’ve picked up that old book on customer service, dusted it off, and put it back into practice. How many times have you left a message and never heard back? How many recruiting firms have you sent your resume to who haven’t called you back promptly? At TalentZök, customer service is our priority. We return calls promptly. We don’t let you fall through the cracks. It sounds so simple yet so few know how to do it right. THE IMPORTANCE OF A FIRM HANDSHAKE There is no substitute for meeting someone in person. It is the only way to really understand people. We interview all of our candidates in person before they interview at our client companies to ensure the best possible fit. We also visit companies in person, meet the people involved in the decision, get a feel for the company culture and get a thorough understanding of the job. We won’t waste your time because we’re committed to understanding exactly what it is you’re looking for.