Engineering Document Control Coordinator
POSITION OBJECTIVE: This position is responsible for supporting Operations, Engineering, computer systems and documentation processing. Coordinates the preparation and change control of Master Batch records, Standard Operating Procedures (SOP) and departmental documentation. Maintains departmental project logs and tracks project status.
Essential Job Functions/Responsibilities
· Develops and drafts new product Master Batch Records (MBR’s)
· Coordinates the Management of Change (MOC) process for Engineering and Operations documentation and MBR’s
· Supports the drafting and processing of protocols, final reports, and other documentation
· Prepares and creates label templates to support all Commercial and Clinical packaging
· Develops an in-depth knowledge of cGMP’s, safety and departmental procedures and policies to establish necessary documentation to support functional operations
· Coordinates documentation of facility and departmental control systems
· Provides input to Quality Assurance issue investigations as requested
· Creates purchase order requisitions to support planned services and preventative maintenance
· Controls the multi-site Pest Management system and all appropriate documentation
· Assists New Product Development with preparation of data in Material Requirements Planning (MRP) systems
· Maintains and controls relevant departmental logbooks
Required Education & Experience:
· Minimum two (2) year technical degree is preferred. Equivalent experience will also be considered
· Minimum of 1-3 years’ experience working in a computerized management software program, preferably in an FDA regulated, cGMP environment or relevant college course work in same
Required Skills & Abilities:
· Must be proficient in office software including Word, Excel, PowerPoint, and Outlook.
· Experience in ERP, QMS, and Computer Systems
· Strong analytical and problem-solving skills
· Ability to quickly make decisions and understand the impact on operations
· Strong team-oriented work ethic; ability to carry out detailed written or oral instructions
· Must be a self-starter; works well both independently and in a team-oriented environment
Preferred Skills & Abilities:
· Knowledge of current Good Manufacturing Practices (cGMP) as they relate to pharmaceutical manufacturing operations
· Strong organizational skills with the ability to prioritize and schedule activities
· Good communication skills – both verbal and written; able to communicate professionally both internally and externally
· Ability to work in an aseptic cleanroom
· Ability to work in a dynamic manufacturing environment
· Ability to lift 25 lbs.
· Travel and overtime may be necessary
Athenex is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, and other legally protected characteristics.
Athenex is committed to working with and providing reasonable accommodations to individuals with disabilities. If you need a reasonable accommodation because of a disability for any part of the employment process, please notify HR and let us know the nature of your request and your contact information.