GMP Record Specialist Supervisor

United States, Hayward (California)

Today, Lonza is a global leader in life sciences operating across three 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.

The GMP Record Specialist Supervisor is responsible for leading a team of GMP record Specialists to develop, revise, maintain and improve quality records (batch records, standard operating procedures, work instructions, training documents, protocols and reports) to support timely initiation of Customer programs, to meet quality management system requirements and to achieve continuous improvement of the document system. 

The role is accountable for, safely and with a compliance and quality mindset, managing departmental priorities to achieve organizational and stakeholder goals, managing team resources, performance and providing mentorship, coaching and development of team members. The role is accountable setting and managing department performance goals through the routine assessment and communication of established metrics.   The role ensures adherence to cGMPs, the document management system (DMS), and established content/format requirements for batch records and standard operating procedures (SOPs).  

By accomplishing this, the team is able to support efficient and compliant data entry into records.  The role requires demonstrated competency in project management, utilization of Microsoft Word processing platforms, Documentum and TrackWise.  
The role requires coordination of multiple departments and cross functional activities through strong meeting facilitation, conflict resolution, real-time troubleshooting, and prompt decision making. 

Key Responsibilities:
•    Edit documents: Review and template all TWG-related documents (e.g. upstream and downstream documents, buffers, media) with accurate, clear, and explicit description and justifications 
•    Independently create new cGMP documents 
•    Manage document comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with aid from document owners while also aiding fellow team members with their own comments to create clear, concise adaptations toward all documents 
•    Maintain and review schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe while learning more about the manufacturing schedule; has a deep understanding of how scheduling works; communicating to group and appropriate departments concerning schedules; distributes workload planning 
•    Provide competency in process mapping/task identification upstream and downstream processes 
•    Serve as primary point of contact for critical document changes 
•    Uphold leadership role: Mentor/coach/train all technical writers.  Manages and achieves self and team training objectives.
•    Provide peer reviews and other support needed by the supervisor, standing in as needed, as well as leading the rest of the team  
•    Drive the interviewing and hiring process 
•    Serve as primary point of contact for critical document changes 
•    Perform other duties as assigned 

Key Requirements:
•    HS Diploma or Associates degree required
•    BS degree preferred in Biochemistry, Chemical Engineering, Biology or other relevant science discipline
•    Intermediate to advanced experience in technical writing
•    Intermediate experience in management and leading a team of direct reports
•    Strong understanding of cGMPs
•    Demonstrated proficiency with Documentum document management systems (DMS)/document control practices and TrackWise systems
•    Strong written and oral communication skills 
•    Advanced proficiency in MS Suite, particularly Word, Project, and Excel
•    High skill level editing/creating tables/templates/macros/templates/various styles using word processing tools
•    Highly organized 
•    Strong attention to detail 
•    Independent worker who works effectively in a team environment 
•    Superior Proofreading/editing

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.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R31967