Compliance Specialist I
Discovery Drive, SWDD Swiftwater, PA
- Authoring and resolution of deviations in order to meet production and product release requirements.
- 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
- 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.
- Bachelor degree and 3-5 years experience.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.