Quality Assurance Specialist

Manufacturing company that services the biotech and medical device industries is looking for a QA Specialist to join their team! Opportunity to expand your skills within technical writing, investigations, internal and external audits, and root cause analysis.

MUST HAVE:

• Excellent written and verbal communication
• Knowledge of QA within GMP or ISO 9001
• Experience running internal and external audits

WHAT'S IN IT FOR YOU:

• Opportunity for a hybrid schedule at 3 months
• Growing company in the process of acquiring multiple manufacturing sites
• Expanding Camarillo lab in 2024

Description:

Collaborate with stakeholders to the management of the Quality System. Recommend and implements changes to the existing quality system with regards to nonconforming product, corrective/preventive actions, document control, quality control inspections and product release, internal audits, validations and equipment calibration and maintenance programs.

Primary Responsibilities:

• Responsible for all activities involving quality assurance and compliance with applicable regulatory requirements.
• Regulatory submissions and compliance with applicable national and international regulations.
• Conducts audits and reviews/analyzes data and documentation. Manage internal audit program and support QMS related activities.
• Host customer audits.
• Perform supplier audits, support supplier audit program.
• Initiate, investigate and complete corrective actions (CA). Participate in the MRB meetings. Includes ability to apply problem solving tools and methods to coordinate and/or lead investigation teams.
• Participate in the management and execution of equipment, process and software validation.
• Manage the equipment calibration and maintenance program.
• Provide directions for all aspects of testing related to manufacturing.
  • First article inspections
  • In-process release inspection.
  • Final QC release of finished goods.
  • Document review.
• Ensures that all inspections and procedures are properly completed and documented.
• Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
• Perform environmental monitoring of cleanrooms and bioburden results. Provides solution for microbial failures.
• Assists department with continuous improvements initiatives or lean projects.
• Can serve as Quality Assurance representative on facility projects.
• Lead/support investigations and response for customer complaints.

Skills:

quality assurance, internal audits, external audits, GMP, document control, ISO 9001, drug manufacturing, regulatory audit, regulatory, change controls, deviation management, EQMS

Experience Level:

Intermediate Level