Document Control Specialist (Biotech)

 

Job Description:

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want to be part of.

We are seeking a self starter, whom under limited supervision is responsible for Document Control activities (includes both physical document filing as well as computer based work). This person should have good working knowledge of standard processes, procedures and timelines. Additionally, they should  demonstrate attention to detail, and have strong oral and written communication skills. Should operate in line with GMP and Lonza  requirements.

Key Responsibilities:

• Active support of Document Management System (DMS), for example implementation and migration of documents. Responsible to conduct document review and approvals in timely manner within scope of job role. Will provide other DMS administrative tasks within software.

• Responsible for management (creation, updates, archival) of various document control team trackers and logs.

• Assists in document lifecycle through creation, editing, review, issuing and archiving of the various document types at Lonza Tampa (batch records, SOPs, protocols, reports, forms, laboratory documents)

• Writes SOPs and manages templates with support from specialist colleagues

• Identifies compliance/non-compliance with procedures and resolves necessary amendments to GMP documentation

•  Reviews GDP and date integrity to ensure that review and archival of all GxP data generated are stored as per relevant protocol, SOP and/or regulatory requirements.

• Complete archiving and virtual archiving of documents (scanning, storing files, archiving hardcopy files) to ensure documents can be accessed for customer enquiries, audits and inspections

•  Running database queries and reports in addition to data entry

•  Prepare/Participate in internal, client and/or regulatory audits as required. 

•  Build close links and working relationships with internal customers in other departments

•  May train new staff in use of company systems (DMS, Learning Management System, general documentation processes)

• Document / Administrative support for deviation management, investigations and change requests

• Developing ability to interpret and apply cGMP regulations

• Receives general instructions on routine work and new projects or assignments.  

•  Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification whenever Safety and Sustainability requirements and expectations are either unknown or unclear

• Promptly report identified Safety and Sustainability issues, problems, deficiencies, errors, incidents, and/or opportunities to management and correct where possible

• Stop work where deemed necessary to maintain safety

• Audit/inspection backroom support

• Learning Management System (LMS) management

• Basic computer skills and preference for experience with Microsoft Suite, Trackwise, Documentum, Cornerstone LMS

• Performs additional job related assignments as requested by Quality management

• Able to build strong and effective working relationships with Quality team, colleagues, and clients

Physical Requirements:
•    Must be able to climb and work from stairs (step ladder)
•    Must be able to bend, push, pull in support of document or cart movements
•    Must be able to sit and stand for moderate periods of time
•    Must be able to lift 25 lbs

Key Qualifications:

HS Diploma required or AAS degree, preferred.    

 2+ years in a regulated work experience    

Preferred Field of Experience:   Pharma cGMP

Every day, Lonza's products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

 

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.