Full review of completed batch records to ensure compliance with cGMP per written procedures 
 

Good understanding of Quality systems (with some guidance) including deviations, CAPA, document change and process change procedures, ensuring required procedures are followed 
 

Compiling batch documentation for lot release in a timely manner per review and release schedule 
 

Ensuring all associated events are investigated and closed prior to lot release 
 

Preparing responses for customer review observations 
 

Providing back room support during regulatory audits 
 

Support other departmental tasks, as needed

Required Skills 


Excellent written and verbal communication skills.

Must have attention to detail and good investigation, problem solving and organizational skills.

Ability to work effectively with people and communicate negative information and obtain positive results.

Works well and facilitates positive interdepartmental interactions with a diverse group of people. Voluntarily communicates needs and suggestions clearly and effectively. Listens and is attentive to others.

Familiarity with SAP, Trackwise, DMS, and LIMS systems an advantage.

Completes assigned tasks on-time. Capable of being flexible as required tasks change and maintain productivity.

Keeps project leads and team members informed of the status of assigned work.

Must be a strong, dependable team player.

Ability to work with Microsoft Office applications.

Resolve differing perspectives with effective negotiation skills.

Properly prioritize tasks, manage time effectively. Positive proactive approach to drive projects to completion.

Required Experience 

 

 

Understands biopharmaceutical manufacturing environment - basic knowledge in cell culture, protein purification, lab processes and validation 

 

Ability to interpret and apply current GMP regulations consistently 

 

Ability to tolerate long hours of desk workPlease apply online at http://www.lonza.com/group/en/company/working/careers.html and click on U.S. Jobs in MA, MD, ME, NH to search for this opening. 

Job Location 

Portsmouth, NH, US. 

Position Type 

Full-Time/Regular 

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