QA Specialist- Pharmaceutical
ESSENTIAL JOB FUNCTIONS
- Performs investigations of non-conformance including customer and consumer complaints and tracks resulting CAPA action plans.
- Conducts cGMP training and maintains training records.
- Administers the product stability program and designs compliant bracketing and matrix strategies for stability profiles.
- Administers the cGMP compliance audit program.
- Develops and maintains SOPs and forms governing areas of responsibility.
- Acts as a liaison with raw material manufacturers and suppliers ensuring compliance with company and regulatory requirements.
- Assists Manager, Quality Assurance in administering the Quality Management Software.
- Monitors regulatory and industry trends/actions and reports regularly to Quality management.
- Develops and maintains performance measurements for areas of responsibility.
- Performs and assumes other duties and responsibilities, as may be required by the Manager, Quality Assurance and/or Director, Quality.
EDUCATION AND EXPERIENCE
- A 4-year college degree in the sciences or related discipline; or equivalent in knowledge and training.
- The knowledge and skills required for this position are typically acquired in 3 to 5 years of experience in a pharmaceutical manufacturing environment.
- Effective interpersonal skills to interact with various levels of internal and external customers and suppliers.
- Must possess comprehensive understanding of cGMP regulations, Standard Operating Procedures (SOPs), and quality assurance policies and procedures (e.g., perform receipt inspection, batch record issuance, and finished product release duties, etc.).
- Thorough knowledge of auditing programs.
- Thorough knowledge of stability programs.
- Computer literate in a Windows environment.
- Establishes priorities and works independently on a multitude of concurrent tasks with little supervision.
- Detail-oriented and prepares comprehensive and accurate documentation.
- Good math aptitude including statistical analysis.
- Good organizational ability.
- Accepts other duties, as assigned.
- Discreet with confidential information to which he/she has access.
- Develops and maintains effective working relationships with internal and external customers and suppliers, functions as a team player, accepts constructive criticism from management, and complies with Company policies.
3-5 Years in Pharmaceutical manufacturing
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