Job Description

QUALITY ASSURANCE SPECIALIST II - SIMPLY BIOTECH

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 Quality Assurance Specialist II at our client, an 'essential business', located in San Diego, CA who possess:

• Associate's or bachelor's degree
• At least 2 years of strong documentation experience in a QA department in life science industries
• Experience with learning management systems (LIMS) and electronic document management systems (EDMS)

Email resumes to acannon@simplybiotech.com or call 858.227.4596

FULL DESCRIPTION:

The selected candidate will further possess:

• Knowledge of Veeva Vault quality applications strongly preferred
• Intermediate to advanced working knowledge of Microsoft Office products, SharePoint
• Superior organizational skills and attention to detail
• Ability to interface effectively with employees from multiple departments and positions within the company

The selected candidate will be responsible for:

Document Control:

• Provide Document Control support for GMP quality systems through Veeva Vault
• Provide expertise as a member of QA Document Control in the creation and management of change controls, external quality events, deviations, CAPAs, and procedural documentation
• Maintain the QA Archive Room and regularly file documents
• Act as a QA reviewer on various QC GMP forms and batch records
• As required, perform QA review and approval for internal change controls, deviations and CAPAs
• Generate and track completion of controlled GMP forms as requested by personnel

Training Administration:

• Coordinate onboarding, job transitions, and offboarding of employees
• Collect paperwork from employees in support of onboarding (CV, JD)
• Complete forms tracking the completion of training administration activities
• Coordinate training assignments by interfacing with hiring managers
• Updating person profiles and assigning training requirements in Veeva Vault
• Maintain employee training binders by uploading group training forms, training material, and employee certificates

Reporting:

• Run regular reports on training completion and follow up with employees on an as needed basis.
• Monitor documents requiring periodic review and initiate workflows for documents that need periodic review
• Run and review reports to monitor completion of change controls and work with owners/QA to finalize change controls that are ready for closure

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

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.