Quality Assurance Engineer

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Location

Chelsea, MA

Summary

The Quality Assurance Engineer is responsible for supporting operations in a GMP Manufacturing Facility.  This engineer role supports Acorda commercial operations providing oversight of production at external suppliers.

Full Description

  • Provides onsite and remote oversight of operations for the production of medical devices and for the packaging of commercial product.
  • Conducts a thorough assessment of executed batch records and investigations in support of the timely release of lots for commercial distribution.
  • Become the key contact for Acorda in overseeing production activities from incoming materials through product release leading to shipment for further processing.
  • Partners with deviation/investigation authors to ensure timely closure of investigations and CAPA activities relevant to batch release. Monitors and provides data for metrics for the management of critical suppliers.
  • Ability to effectively communicate with suppliers to optimize processes to mitigate quality events,
  • Ensures that investigations are thorough and that CAPA are appropriate for elimination of root cause and prevention of reoccurrence. Verifies effectiveness of CAPAs. 
  • Supports change management for Operations, including SOP revisions, batch record revisions, and any associated change controls.
  • Supports project deadlines and ensures performance standards are met.
  • 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 an engineering or scientific discipline is required.
  • Minimum of five to seven years of progressive experience in a GMP environment required.
  • Experience in Supplier Quality in a manufacturing environment preferred. 

Supervisory Responsibilities: None

Qualifications:

  • Working knowledge of GMPs and their application to medical device, pharmaceutical, and packaging manufacturing processes required.
  • Knowledge of FDA guidance documents is required particularly with medical devices.

Computer Skills:

  • Must be proficient in MS Office Suite. Must be able to efficiently edit content and formatting and create spreadsheets and presentations.

Certificates, Licenses, Registrations: CQE and/or CQA, preferred

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 travel; travel for this position is up to 25% 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.