Senior Specialist Quality, Exton, PA

 

Senior Specialist, Quality

Exton, PA

Monday - Friday, 8:00am - 4:30pm                                                                               

 

The Senior Specialist, Quality is a business unit function with site responsibility within the quality assurance functionalities. You will have thorough knowledge in reviewing batch production records, specifically batch production records for medical devices, to ensure compliance to internal and customer requirements as well as cGMP and applicable regulatory requirements.  You will review all pertinent records, including batch production records and laboratory Certificates of Analysis to confirm accuracy and makes the determination of acceptability for product release.

This is the last stop before orders go out to customers so if you have excellent attention to detail, experience with SAP, Arena and LIMS, have a Quality mindset, and possibly medical device experience please apply now!

 

dsm-firmenich Biomedical is the world’s unrivaled biomaterials expert and committed partner in driving sustainable innovation in healthcare. For more than 30 years, the company has been at the forefront of biomaterial science and process innovation, and the leading resource for global medical device and pharmaceutical companies.

  

Responsibilities:

 

• The Senior Specialist, Quality reviews all pertinent records, including Batch Production Records and Certificates of Analysis / Conformance to confirm accuracy and without supervision, makes the determination of acceptability for product release. In addition, confirms that all related Quality events such as deviations, nonconformances, change control, corrective and preventive actions, etc. are closed or adequately addressed prior to releasing the product.
• Partners with other departments to ensure that errors are addressed and corrected. Identifies errors that have potential product impact, escalates to supervision as appropriate, and takes action to disposition product as needed. Ensures release meets internal requirements and is performed in a timely and accurate manner.
• Collaborates with quality, manufacturing, warehouse personnel to correct errors and address Non-Conformances and /or disposition product in a timely manner.
• Review batch production records to ensure compliance with all internal and external key quality attributes and release in electronic management system (SAP). Performs SAP transactions to release product.
• Review test data and all other data and ensure all other input documentation required for batch release is up to date and compliant. Responsible for ensuring compliance with regulatory requirements related to product safety and quality.
• Reviews batch production records to ensure data meets the industry requirements for data integrity. 

 

We offer:

 

• Paid holiday, 18 days PTO + 2 floating holidays
• Full healthcare benefits day one – medical, dental, eye, and life insurance.
• 401K with generous company match

• Unique career paths across health, nutrition and beauty - explore what drives you and get the support to make it happen
• A chance to impact millions of consumers every day – sustainability embedded in all we do
• A science led company, cutting edge research and creativity everywhere – from biotech breakthroughs to sustainability game-changers, you’ll work on what’s next
• Growth that keeps up with you – you join an industry leader that will develop your expertise and leadership
• A culture that lifts you up – with collaborative teams, shared wins, and people who cheer each other on.
• A community where your voice matters – it is essential to serve our customers well. 

 

You bring:

 

• Bachelor’s degree in related discipline with 3+ years’ relevant experience, including at least 1 year in Quality operations.

• Experience: 3-5 years