Compliance Specialist
Malvern, PA, US
5d ago

Compliance Specialist Malvern, PA Duties : -The Compliance Specialist supports the maintenance of all Good Manufacturing Practice / European Union documentation related to the packaging of clinical investigational product, the maintenance and distribution control of master batch records, protocol specific product information files, production batch records, entering / updating / distribution of standard operating procedures, lesson plans, training records, updating / distribution of HSE risk assessments, completed batch documentation history, updating the packaging Master Study Schedule and man-

days for each study, enters and ensures accuracy of the data within the production planning / scheduling tools for Packaging Operations, and Clinical Packaging Operations archives.

  • This position supports the Department during internal and external regulatory audits and is a key member of the Departmental audit team.
  • Requirements : -Bachelor’s degree in an Administrative or Business discipline -Minimum of 2 years’ experience in handling planning, training, batch record, and SOP documentation in a GMP / EU regulated environment.

  • Certificates of training in planning software, advanced word processing, basic spreadsheets and basic database use (or equivalent demonstrated skills).
  • Detail and quality-oriented. -Excellent administrative, organizational, proofreading and communication (verbal and written) skills.
  • Ability to independently prioritize and multitask with minimal supervision in a team-oriented, production environment. -
  • Experience using planning software (i.e., Microsoft Project, OPX2, Optime) is required. -Certification in Information / Documentation management or planning or equivalent experience.

  • Background in organizing and maintaining a secure file / documentation room. -Training database entry / retrieval use. -
  • Experience supporting or in auditing departmental documentation. -Certification / training in GMPs / EU regulations. About Tech USA : Tech USA, Scientific Solutions is a comprehensive provider of staffing and workforce solutions throughout the Scientific Industry, including Biotechnology, Pharmaceutical, Clinical Research, Healthcare, Biodefense, Environmental, Chemical and Food Sciences.

  • We are actively seeking candidates for contract, contract-to-hire and permanent placement jobs throughout the nation. View our website to see a list of our current open positions;
  • however, not all of our positions are listed so don’t forget to submit your resume and request a consultation with one of our scientific recruiting specialists to explore your opportunities further.

    At Tech USA we understand that next to your family, your career is one of the most important aspects to a happy and fulfilling life.

    This is why we take the time to truly understand and get to know our candidates, so we can then pair them with the right job, not just any job.

    As a result, Tech USA is known throughout the industry for quality, reliability and the highest satisfaction from both our clients as well as the candidates that we represent.

    Tech USA is an equal opportunity employer.

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