Technical Quality Assurance Manager / Senior Manag job in South San Francisco, CA| Recruit Arrow
Recruit Arrow
Email Password
Forgot your password?
Welcome, Guest! New User?
Tell a Friend
Success Stories
From my very first contact with Recruit Arrow, through the application process, interviews, and my acceptance of the position, this service was an invaluable asset. My recruiter gave me insight into the company by sharing her own experiences and views.


Job Search

What


 job title, keywords

Where


 city, state, zip






JOB CENTER

Your Window to a World of Opportunities


Welcome to Recruit Arrow's Job Center. We offer you the ability to stay current in numerous specialized job markets, including marketing, advertising, and engineering just to name a few, by subscribing to our Newsletter and Real-Time Job Updates; to subscribe click here.

If you do not yet have an account with Recruit Arrow, we encourage you to sign up for a new account by submitting your resume. An account will allow you to make our search consultants aware of the jobs that you are interested in, view new jobs that match your search settings, modify your search settings, submit a new resume, and take advantage of other useful features.

We are pleased that your assessment of options has led you to Recruit Arrow, and we invite you to browse our website to learn more about our firm and the career opportunities we offer. If you would like to be considered for an professional position, feel free to submit your resume.


Select from the options below to begin your search.


Locations:
(hold down ctrl to choose multiple locations)
City Name:

Primary Field:

Minimum Years of Experience:

Keyword:

1 matches | 1 - 1 displayed 
 1 

Title
Technical Quality Assurance Manager / Senior Manag
Location : California, South San Francisco
Refer job # TEOQ338274
 
Job Responsibilities and Requirements: Essential Functions: Serve as a QA member in the CMC Team and have the ability to manage across functional boundaries. Develop master batch records with Process Chemists and Formulators. Participate and sometimes lead external audits for the assigned CMOs, labs and suppliers. Responsible for document control records of new and revised test methods, work instructions, specifications, protocols, reports, forms, and templates. Review, approve and manage internal and external product documentation (i.e. master batch records, executed batch records, test methods, specifications, protocols, reports, forms, and etc.). Coordinate the review and approval of internal and external deviations, investigations, CAPA and Change Control. Negotiate Quality Agreements and define Statements of Work pertaining to quality requirements. Write procedures and work instructions and support document review and approval of QA documents as requested. Support Quality Management System (QMS) projects and activities as needed. Provide data for trending for the QMS for the Quality System Management Reviews (QSMR). Provide information for Annual Product Reviews or routine reports as needed. Support GxP QA Operations in document review as needed. Support FDA inspections and preparations for Pre-Approval Inspections (PAI) and internal audits. Preferred Experience: At least 10 years of GMP quality experience in pharmaceutical/biotechnology industry. Batch record review and Quality Control experience. Small molecule experience (solid dose, API, parenterals). Working knowledge of 21CFR Parts 11, 210, 211, 820; ICH, and GxP regulations. Computer proficiency in Microsoft Word, Office, Excel, PowerPoint, Adobe Acrobat Pro, electronic database system, etc. Clinical and commercial experience and ability to be flexible without losing quality focus. Preferred Education: BS/BA in scientific discipline or equivalent. Preferred Additional Skills: Strong organizational and attention to details skills. Ability to adapt to a fast paced and changing work environment. Displays emotional resilience and the ability to withstand pressure. Communication skills in regard to interaction within GxP and associated customers. Committed to the values of integrity, accountability, transparency, scientific rigor and drive. Current US work authorization required. Ability to travel domestically and internationally.
 
Contact the Following Recruit Arrow Office:
Los Angeles
202 S Lake Ave, Unit 250
Pasadena, California 91101
Email: jobs@recruitarrow.com
 
[Apply Now] [Email to a Colleague] [Permalink]

Tweet This



1 matches | 1 - 1 displayed 
 1 
Newsletter and Job Updates