Sr. Quality Assurance Specialist – Data Integrity/CAPA Specialist
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The Senior Quality Assurance Specialist - Data Integrity/Corrective and Preventative Actions (CAPA) Specialist is responsible for supporting operations in a GMP Manufacturing Facility. This Specialist directly supports Quality Control and Analytical Development activities in addition to other Operational activities.
Essential Duties and Responsibilities include the following. Other duties may be assigned:
- Leads coordination of Laboratory and/or Quality Investigations, including investigation plans, and cross-functional discussions and root cause analyses. Assesses and identifies risk and evaluates deficiencies while partnering with system/business owners to develop remediation plans.
- Provides thorough assessment of CAPA activities and documentation to ensure technical consistency and accuracy and compliance with company standards and procedures.
- Partners with deviation/investigation authors to ensure timely closure of CAPA. Monitors and reports metrics for the CAPA system including on-time closures.
- Ensures that investigations are thorough and that CAPA are appropriate for elimination of root cause and prevention of reoccurrence. Verifies effectiveness of CAPAs.
- Reviews and approves Certificates of Analysis for Raw Materials, Intermediates, and Finished Goods.
- Conducts audits of analytical data integrity for data generated for Raw Materials, Intermediates, and Finished Goods.
- Conducts audits of Laboratory Operations for compliance to industry and company expectations and requirements.
- Reviews and approves Analytical Test Methods, SOPs, Protocols, Reports and Specifications.
- Reviews Stability Studies – protocols, analytical data, and trends/reports.
- Facilitates internal training on quality assurance requirements, processes, and procedures.
- Supports project deadlines and ensures performance standards are met.
- Ensures compliance with all Acorda policies and procedures including safety rules and regulations
- Provides basic support during compliance inspections conducted by external sources (i.e. health authorities.)
- Suggests resolution of compliance concerns to management.
Education and/or Experience:
- Bachelor’s degree in a scientific discipline is required, preferably in physical Science or Chemistry
- Minimum of seven to ten years of progressive experience in a GMP environment required.
- Experience in Quality Control preferred.
Supervisory Responsibilities: None
- Working knowledge of GMPs and their application to pharmaceutical manufacturing required.
- Knowledge of FDA guidance documents is required.
- Knowledge of current FDA trends and use of FDA website tools required.
- Must be proficient in MS Office Suite. Must be able to efficiently edit content and formatting and create flow diagrams.
- Experience in the use of electronic Quality Management Systems (e.g. Trackwise, for CAPA)
Certificates, Licenses, Registrations: none required
Other Skills and Abilities:
- Excellent oral and written communication skills.
- Ability to navigate multiple projects with changing priorities and to execute project timelines in a fast-paced environment.
- Ability to work both independently and ability to collaborate effectively with subject matter experts in a cross-functional team environment.
- Excellent organizational skills with attention to detail.
- Demonstrates appropriate safety consciousness.
The physical demands here are representative of those that must be met by an employee to successfully perform the essential functions of this job.
- This position requires minimal travel; average travel for this position is 5-10% with some variation based upon the demands of the business imperatives.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.
No specific work demands.
*To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.