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Quality Compliance Specialist I - cGMP, continuous improvement

Apex Life Sciences is looking for a Compliance Specialist in the Swiftwater, PA area


Responsibilities



  • 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


Qualifications



  • Bachelor of Science and 3-5 years? experience in Quality Assurance required

  • 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

  • Must be able to work extended and flexible hours (including weekends) when needed


For immediate consideration, please email your updated resume to Click Here to Email Your Resum? with 'Quality?Compliance Specialist PA' in the subject line










EEO Employer


Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178
 


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