Data Entry- Pharmaceutical

About The Role

This position involves supervising the development, creation, and revision of controlled documentation in compliance with company policies, procedures, and industry standards such as GMP, 21

CFR
820, ISO 13485, and AATB Standards. The role requires collaboration with various managers and supervisors across local and global functions, as well as working with Change Control, Quality Investigations/CAPA team members, and other cross-functional teams to ensure the accuracy of controlled documents. The individual will serve as a primary contact for change initiators, provide guidance on processes, and represent Quality Documentation and Change Control during regulatory audits.

Additionally, the role includes fulfilling the responsibilities of the Change Control Manager in their absence and leading the team by providing guidance and direction.

Responsibilities:

• Author changes to controlled documentation, including standard operating procedures, work instructions, batch records, and forms.
• Act as Initiator for Change Controls, managing complex tasks and tight deadlines to ensure timely completion of changes.
• Serve as a subject matter expert in document creation, format, and alteration, as well as EDMS use.
• Participate actively in cross-functional collaborative efforts, attending team meetings and working with project team members to develop document content.
• Support 5S methodology to maintain a safe and pleasant working environment.
• Process controlled documentation in the EDMS in accordance with policies and procedures.
• Review and evaluate change requests of varying complexity with minimal supervision.
• Evaluate objective data associated with change requests and follow up on closure activities.
• Collaborate with internal and external customers.
• Develop and implement process improvements regarding electronic document management system methods and provide training to support staff.
• Represent Documentation and Change Control during regulatory audits.
• Communicate with management routinely and escalate issues as needed.

Education

Qualification:

Bachelor's degree or 5-7 years of equivalent experience.

Required Skills:

3-5 years of experience in a technical writing position within a pharmaceutical, medical device, or biotech company. In-depth knowledge of MS Word, including the use of tables, headers/footers, and review capabilities. In-depth knowledge of EDMS (One Vault) and ERP System. Project Management capabilities.

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually – as applicable. Payrange: $20/hr to $25/hr