Senior Quality Assurance Specialist - Data Integrity/CAPA Specialist

Apply for this position

Location

Chelsea, MA, United States

Summary

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.

Full Description

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

Qualifications:

  • 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.

Computer Skills:

  • 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.

Physical Demands:

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.

Work Environment:

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.