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Quality Assurance Specialist Chemistry, Biochemistry or Chemical-11352

TalentZok Torrance ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

 

Quality Assurance Specialist- TalentZok

OVERVIEW

Are you looking for a new career opportunity with an exciting company?! Then we’ve got the right team for you! In this role, you’re responsible for the duties listed below.

 

Immediate opening for a Quality Assurance Specialist in Torrance, CA who possesses:

  • Experience in quality assurance in the cGMP active pharmaceutical ingredient contract manufacturing industry or Pharmaceutical Company-3 yrs.
  • FDA, EMEA Inspections Experience
  • BS in Chemistry, Biochemistry or Chemical Engineering
  • API Exp a +


Email resumes to lbinfo@talentzok.com and call 424.488.7106

 

FULL DESCRIPTION:

 

Work directly with the Director/Manager & Supervisor, Quality Assurance (Operations) to maintain, help develop and implement all aspects of a proactive Quality Assurance Systems. The system and manufacturing operations (quality policies, procedures, and finished product release) must adhere to FDA and global regulatory organizations. Assure compliance with FDA & EU regulations, ICH guidelines and State of California regulations.

 

The selected candidate will further possess:

  • Minimum undergraduate degree in Chemistry, Biochemistry or Chemical Engineering.
  • Two years of industry relevant experience.
  • Experience in quality assurance in the cGMP active pharmaceutical ingredient contract manufacturing industry or Pharmaceutical Company that internally produces their APIs is a plus.
  • Some API manufacturing experience is a plus.
  • Experience in FDA, EMEA inspections with documented successful outcomes.
  • Demonstrated ability to apply comprehensive, in-depth understanding of pharmaceutical industry manufacturing of APIs with emphasis on cGMP, IND, and NDAs.
  • Excellent technical writing skills and effective communication skills
  • Effective management of relationships with FDA, pharmaceutical and biotechnology customers
  • Experience in all aspects of Quality Assurance from preclinical to commercial product phases (phase appropriate cGMPs).
  • Ability to manage multiple tasks, deadlines and priorities. Must collaborate across organization and functional boundaries including customers as a team player and occasional team leader.

 

The selected candidate will be responsible for the following:

·

    • Participate and contribute through team functions: deviations, batch record review, annual product review, QC data review, C of A generation for clinical and commercial product release Updating of SOPs, Material Review Reports, and interaction with contract testing labs
    • Actively participate in supporting supplier audits, change control, CAPA, complaint handling, document control systems, and cGMP training of employees. This also includes working on deviations, batch record review, and clinical and commercial product release. Enter data into databases in accurate and timely manner
    • Ensure that Quality System, cGMP and ICH guidelines are adhered to 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.
    • Collaborate 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 record of accomplishment with FDA and other regulatory agencies
    • Excellent oral and written communications skills

 

For immediate and confidential consideration, please email your resume to info@TalentZok.com or call 424.488.7106.

More information can be found at www.TalentZok.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.

TalentZok

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.

Address

Torrance, CA
USA

Website