Under the supervision of the Reagent Manufacturing Document Manager, works with the Reagent Manufacturing team to create and revise manufacturing documents. Documents include work instructions (WIDs), standard operating procedures (SOPs), etc. to ensure they are in harmony with the manufacturing process and comply with regulatory standards. Also creates and updates change control documents for these processes, and coordinates and supports the validation of manufacturing batch records.
Essential Job Duties and Responsibilities:
- Perform all work in compliance with company policy and within the guidelines of Biomerieux SLC’s Quality System.
- Creation and revision of cGMP documentation including Production Work Instruction Documents (WIDs), standard operating procedures (SOPs), control plans, and materials specification sheets.
- Creation and revision of change control documentation including technical reviews for process change, change notifications, change orders, temporary deviations, and batch record validations.
- Coordination of timelines, document revisions and review cycles for all cGMP documents in Reagent Manufacturing including delegation to the appropriate groups for review to ensure timely project start dates and to facilitate overlapping projects.
- Coordinate and expedite the review and implementation of change orders and other change control documents.
- Driving the continual improvement of Reagent Manufacturing work instruction documents by soliciting and incorporating feedback from process experts, area supervisors, Quality Assurance.
- Works with QA (Document Control) to ensure best documentation practices.
- Promote Quality System Requirements (QSR) and regulatory compliance into assigned projects.
- Supports project management team to ensure timely delivery of documentation for projects.
- Performs other duties as assigned.
Training and Education:
High school diploma or equivalent required. BS in Biological Sciences, Chemistry, Chemical Engineering or related discipline is preferred. A BS/BA in another field can be substituted with the addition of other relevant experience.
Experience:
Minimum two years of experience in a cGMP manufacturing environment. Previous experience writing WIDs or SOPs in a cGMP environment is preferred.
Knowledge, Skills and Abilities:
- Proficiency in Microsoft Office suite including word, excel, outlook and PowerPoint is required.
- Effective in written and oral communication.
- Mandatory professional skills including knowledge of cGMPs in a related industry.
- Organized and disciplined record keeping.
- Must work well independently as well as in a team environment
- Ability to work effectively with others in a dynamic environment.
- Ability to self-motivate, multitask, and meet tight deadlines.
- Ability to present information and lead meeting discussions.
