Authoring and resolution of deviations in order to meet production and product release requirements.
location: Swiftwater, Pennsylvania
job type: Contract
salary: $22.62 - 26.61 per hour
work hours: 9 to 5
- Identification and facilitation of interdepartmental process improvements.
- Utilize root cause analysis techniques during deviation investigational process
- Work cross functionally, to develop and implement continuous process improvements
- Support production needs and continuous improvement including change control, deviation writing / review, CAPA implementation, and operational optimization.
- Collaboration with Technical Writers to write, review, revise and prepare manufacturing documents (BPR, SOP, SWI, etc) in accordance with cGMP and regulatory guidelines.
- Communicate across multiple groups and levels to obtain consensus in order to facilitate deviation closure
- Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization
- Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
- Will be responsible for performing administrative tasks such as gathering and preparing documentation to support investigations and or change controls/capas
- Bachelor Degree and 3-5 years' experience.
- Working knowledge of cGMP's is required.
- Must have knowledge of continuous improvement techniques and problem solving skills.
- Previous experience working within a production department of a pharmaceutical company.
- Technical Writing experience preferred.
- Candidate must be able to work extended and flexible hours (including weekends) when needed.
skills: SOP, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.