Quality Assurance Engineer
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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.
- 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
- 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.
- 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.
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.
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.