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Quality Assurance Specialist
Posted Friday, July 14, 2023
Posting ID: JP-003907039
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.
- 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
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.
- 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.
quality assurance, internal audits, external audits, GMP, document control, ISO 9001, drug manufacturing, regulatory audit, regulatory, change controls, deviation management, EQMS
Recruiter: Aileen Garland
Phone: (310) 800-9092