At Pacira Pharmaceuticals, controlling postsurgical pain is the key to improving patient outcomes. Our in-depth knowledge of the needs of the postsurgical pain market, coupled with our passion for delivering improved patient care, drives our commitment to providing solutions that address unmet medical needs and improve clinical results. Pacira Pharmaceuticals currently has an opening for a Senior QA Engineer.
This purpose of this position is to provide Quality technical support to the organization. Focus will be on GMP compliance. Strong emphasis on evaluation of Quality Events (deviations, investigations) to ensure sound scientific rational, compliance to GMPs and Pacira standards. Ensures that risk assessment is adequately performed, root cause determined and appropriate CAPAs are identified. Takes an active role in manufacturing investigations. Identifies risk and evaluates deficiencies while working withinternal departments/business units to appropriately remedy them.
- With little supervision, evaluate and provide Quality Assurance review and approval of Deviations, Issues, and OOS. Actively track and monitor deviations ensuring timely closure.
- Ensure deviations are thorough, scientifically sound and GMP compliant.
- Assist in determination of Corrective and Preventive Actions (CAPAs), track and manage until closure.
- As required, review and approve Change Control documentation ensuring scientifically sound justification and compliance to GMPs
- Write, review and revise GMP documents as needed.
- Partner with Manufacturing Technical Support, Validations and Engineering to support special projects.
- Lead or support manufacturing investigations ensuring root cause, product impact and CAPAS are determined.
- Assist with regulatory inspections and partner audits.
- Provide QA guidance to other departments on quality impacting issues.
- As required, act as QA representative on project teams to ensure path forward is compliant and provide technical QA support to resolve issues.
- Other duties as assigned
Education and Experience:
· Minimum 8 years of relevant experience in Quality Assurance in the pharmaceutical industry.
· BS/BA degree in scientific discipline or equivalent experience.
· Aseptic manufacturing experience a plus
- Strong knowledge of GMP’s and their application
- Prior experience with deviation and OOS review and approval required
- Problem solving and root cause analyses methodology
- Ability to manage multiple responsibilities with a high degree of self-motivation and independence to ensure established timelines are met
- Knowledge of MasterControl a plus.
- Good written, oral and interpersonal communication skills
- Ability to use Microsoft Word and Excel applications
- With minimal supervision, prioritize activities to meet established timelines