Review/approve batch record packets and associated documentation. Assure compliance to Pharmaceutical Regulations and Good Manufacturing Practices. Support manufacturing areas by performing in-process QA checks, sampling, and other related activities. Provide quality approvals in materials management system as defined by procedures. Write/review/approve exception documents and corrective actions/preventive actions (CA/PA) and ensure they meet timeliness requirements.
Review/approve clinical documentation and specifications, as applicable. Write/review policies/processes/procedures and related documents. Assist in the preparation of audits conducted by regulatory agencies, customers, internal groups. Actively participate on assigned project team(s) to support the product development process by using expertise to anticipate/resolve quality issues and take preventive actions. Generate and report quality metrics to management.
Participate with support groups in developing/prioritizing QA activity timelines. Actively monitor the effectiveness of processes and quality of project work with management, and propose and execute quality/process improvements. Ensures integrity, accuracy, consistency and completeness of area of responsibility. Completes projects as assigned by management. Minimum Experience1 – 2 years experience in Quality Assurance or related field.
Preferred healthcare industry and specific experience in quality function. General understanding of US and international regulations for quality systems and compliance. Experience in coordination and planning of activities. Demonstrated organizational skills. Interpersonal and team negotiation skills to handle multiple priorities. Ability to build and maintain credibility across functional disciplines. Effective use of oral and written communication skills to clearly communicate the quality position, and the actions necessary to resolve issues.
Ability to identify and resolve
Enter qualifications hereTO BE CONSIDERED FOR THIS POSITION IMMEDIATELY (Email ALL OF THE FOLLOWING as an attachment)
1.) RESUME, (REQUIRED)
2.) HIGH SCHOOL DIPLOMA or GED, (REQUIRED)
3.) COVER LETTER, (REQUIRED)
4.) Vaccination records of the last year TB AND HBV (IF YOU HAVE THIS)
All applications failing to follow these instructions will be deleted BEFORE consideration.
Job details are sourced from the employer's original posting.
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