Essential Responsibilities
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Comprehension and the ability to produce at a minimum the following:
- User Requirement Specifications (URS)
- Engineering Studies (ES)
- Master Batch Records (MBR)
- Artwork Masters (AW)
- Work Instructions (WI)
- Standard Operating Procedures (SOP)
- Change Requests (CR)
- Document Control Module Requests (DCM)
- Ensures standardization of documents.
- Interacts and collaborates with technical personnel documenting content in a concise and coherent manner for both technical and non-technical personnel.
- Utilizes controlled document archive (EtQ).
- Utilizes, manipulates, and incorporates image files as appropriate.
- Attends meetings pertinent to written documents and redlines, updates and incorporates as required.
- Makes recommendations for content and format of written documents.
- Ensures alignment or written production documents with applicable requirements (customer & internal).
- Participates in document reviews.
- Writes CRs and DCMs as necessary for document changes.
- Works independently and in team environment.
- Can gather missing information from various sources (electronic and employee).
- Works to deadlines and project timelines.
- Can convey all steps and sequence thereof to help establish timelines.
- Manages multiple projects in parallel and communicates constraints appropriately.
- Adheres to group operating procedures.
- Ability to lead review of documents.
- Mentors in areas of expertise as necessary.
- Adhere to company safety requirements.
- Regular attendance.
- Other duties as assigned.
- Comprehension and the ability to produce at a minimum the following:
Minimum Requirements
MINIMUM REQUIREMENTS:
- Knowledge of company practices to develop technical documentation.
- Prior experience writing technical documents.
- Four-year college degree or five years or more of experience in a comparable position.
- Prior experience in a FDA-regulated manufacturing facility preferred.
- Knowledge of GMP requirements preferred.
- Experience formatting documents to comply with established guidelines.
- Ability to follow written and oral instruction.
- Strong organizational skills.
- Strong interpersonal skills to communicate effectively at all levels within the organization.
- Proven ability to meet established timelines.
- Ability to work both independently and as a member of a team.
- Good attention to detail.
- Proficient with Microsoft Office products, including Word and Excel.
PHYSICAL REQUIREMENTS
- Frequently required to sit, talk, and hear.
- Frequently required to stand and walk.
- Regularly required to lift and/or move up to 25 pounds (12 kg).
- Vision ability including close vision, distance vision, color vision and the ability to adjust focus.
Reasonable accommodation may be made to enable those individuals who are disabled as defined by the Americans with Disabilities Act to perform the essential functions of this job.
Pay Range: $60,000-$85,000 depending on experience