Quality Assurance Specialist I

2 weeks ago

davis, United States Ultimate Staffing Full time

Position Summary: Quality Assurance Specialist III

Description: Under minimal supervision, responsible for a variety of tasks necessary to implement and maintain the Quality Management System. This includes nonconformance, deviation management, CAPA investigations. Document and change records control, internal/external audits, QMS processes, training, and corrective actions.

In this role, you will act as an SME for our quality team that provides direct manufacturing quality oversight. You will partner with manufacturing and other stakeholders at the site and apply your knowledge of regulations and industry standards, acting as a mentor and coach for the organization.

Position Responsibilities:

  • Review in-process and sub-assembly batch records and perform product release activities.
  • Manage Corrective and Preventative (CAPA) process / records to ensure compliance and timely completion of actions.
  • Develop new approaches to complex problems and lead others to solve the problem through coaching conversations.
  • Manage Quality oversight of ES suppliers and raw materials, including qualification and requalification activities.
  • Provide QA on the floor support during manufacturing operations, as needed.
  • Manage deviation and non-conformances occurring with in-process and finished products.
  • Assist as needed with the External and Internal Audits.
  • Working with appropriate departmental management or SMEs, initiate and implement change activities related to product or process changes.
  • Performs risk assessment and root cause analysis as part of deviation evaluation.
  • Perform incoming receiving inspections activities and release of material for manufacturing.
  • Serve as a senior quality resource to navigate complex issues.
  • Support the strategic priorities of the Company and Quality function
  • Support company policies and procedures.
  • Promotes a culture of trust, collaboration, feedback and speaking up by modeling desired behavior.

Skills

  • Strong interpersonal, written and communication skills.
  • Has good technical decision-making skills, and can troubleshoot and resolve complex issues.
  • Effectively works independently, as well as, in a team environment.
  • Detail oriented and ability to multitask.
  • Microsoft Office/ Word/Excel/ Power Point Proficient.
  • Net Suite, SAP, or similar ERP programs highly desirable.

Education and Experience

  • Bachelor's degree or equivalent in a related life science/technical discipline.

Minimum 5 years' experience working in a regulated Manufacturing, Medical Device, Biotechnology or Pharmaceutical Environment and/ or combination of education and experience

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. To the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.

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