Individual is responsible for manufacturing support activities that include event investigation, CAPA, and business process improvements. Responsibilities include developing team strategy for the manufacturing compliance team to support B5 and B8 manufacturing. This individual will be responsible for driving down the cost of non-value added activities, developing and executing strategies to achieve department goals. Essential Duties and Responsibilities
- Works with a cross functional team to ensure that compliance gaps are appropriately addressed.
- Using investigation/lean tools, develops robust root cause analysis and drives robust actions to ensure elimination of root cause.
- Ensure projects/improvements are implemented within the stated goals and timelines.
- Creates and develops management tools, mechanisms for monitoring projects and key matrices.
- Interacts through program updates and reviews with all levels of management
- Approves team's deliverables for project completion
- Provides technical support in all phases of the investigation
- Leads team in defining program strategies, developing goals, assigning project tasks and ensures the team meets all goals. Provides performance evaluation feedbacks to team members.
- Other duties as assigned.
Education and/or experience
- Good written and verbal communication skills in English and understanding of cGMP regulations.
- Must be able to read and follow detailed written instructions.
- Math and computer skills (Microsoft Office programs such as Powerpoint, Excel, Word, Project).
- Must be able to complete tasks with minimal supervision, prioritize multiple tasks, and manage time effectively.
- Detail oriented and effectively organize documentation for review.
- Must be able to independently recommend and suggest solutions.
- Good interpersonal skills to work effectively and efficiently in a team environment.
Bachelor degree (science/technical/engineering discipline preferred)
5-7 years related experience
Specialized knowledge in biopharmaceutical industry a plus Physical Demands
Must be able to lift, push, pull and carry up to 15 lbs.
In general, the work requires a substantial amount of sedentary work that includes typing and computer interactions with some walking around observing conditions in the facility. Working Environment
Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
Will work in a cold, wet environment.
Must be able to work multiple shifts, including weekends.
Must be able to work overtime as required.
May be required to work in a confined area.
Some clean room and cool/hot storage conditions.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.