Quality Assurance Specialist Chemistry, Biochemistry or Chemical-11352

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