Documentation Specialist Operations

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

Job Description

The Documentation Specialist - Operations Cleaning Validation will provide direct support to the Production team for documentation, execution and training activities. This role is essential in ensuring the accuracy and compliance of Cleaning Validation and Verification Documentation. They will also assist on the Batch Manufacturing Records (BMR) and other production documentation. The specialist will also support and deliver training for the production team on documentation completion.

Responsibilities

• Primarily to write, train, perform and review Cleaning Validation documentation
• Assist / lead the execution of the Cleaning Validation runs in production
• To hold a Bronze license capabilities to perform entry into all production area
• Ensuring the timely closure of Cleaning Validation documentation and batch manufacturing steps in SAP
• Supporting the review of batch manufacturing records, including trending of errors and feedback to production operators to ensure continuous improvement.
• Provide support on documentation required for production
• Draft of the manufacturing documentation (Master Batch Record), in collaboration with the Technology Transfer and the Cleaning & Process Validation group
• Authoring and reviewing production documentation, such as Standard Operating Procedures (SOPs), Training Forms, Risk Assessments, and Audit Trail Reviews using the Electronic Documentation Management System.
• Coordinating investigations in error to generate preventative actions
• Own change control related to BMR and documentation.
• Attend Tier 1 huddles to update teams on relevant Batch Record position
• Brief Operators and team at the huddle of the oncoming Validation runs requirement
• Track Progress of Batch Record review
• Using Practical Process Improvement to drive improvement initiative of our Batch Record and other documentations.

Minimum Requirements/Qualifications:

To thrive in this role, you should possess the following qualifications and experience:

• Proven working knowledge of the principles and guidelines for Good Manufacturing Practice (GMP) related to production activities, documentation, and data integrity requirements.
• A minimum of 5 years’ experience in pharmaceutical manufacturing, with a preference for specific experience in sterile filtration products.
• Strong proficiency in Microsoft Office applications and a high level of general computer literacy. 
• Experience with change control processes and workflow management
• Ability to collaborate effectively with cross-functional teams
• Self-directed with proven project management capabilities

Benefits

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!