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  1. Jobstinger
  2. North Carolina
  3. Morrisville
  4. Software/QA/DBA/etc
  5. Sr. Compliance Specialist
  • ID
    #12267391
  • Job type
    Permanent
  • Salary
    TBD
  • Source
    Apex Systems
  • Date
    2021-04-14
  • Deadline
    2021-06-13

Sr. Compliance Specialist

 North Carolina, Morrisville, 27560 Morrisville USA
 
Permanent

Vacancy expired!

Our client is currently hiring for an Sr. Compliance Specialist with 5-7 years' experience in pharma dealing with customer complaints for a large global CDMO in Morrisville, NC. Qualified candidates have QA experience in the pharmaceutical industry and experience with technical investigation & batch record review.

If interested, please send a copy of your most updated resume to Sarah at !

Position Title: Senior Compliance Specialist I. Position Overview: The position is responsible for batch record review and customer complaint investigation and technical writing and internal data management related to the quality and/or regulatory disciplines at the Morrisville site.

II. Essential Functions:
  • Initiation, investigation and responding to customer complaints
  • Complaint sample receipt, initial inspection, documentation verification
  • Complaint initiation in TrackWise system, Initial customer notification
  • Sample submission to lab with request for analysis
  • Non - Product Quality related sample handling associated with internal sample storage as well as coordination with off-site storage facility.
  • Retain sample management associated with complaint investigation
  • Compiling and generation data in support of complaints, Continuous Process Verification (CPV) and Annual Product Reviews (APRs) for all commercial customers.
  • Batch record review, data gathering and other investigation related support for complaints
  • Customer complaints investigation and technical write up
  • Leads complex customer complaint investigations
  • Prepares and coordinates investigation approach with testing lab as required
  • Metric/dashboard maintenance; includes collecting data, producing graphs/ charts/ summarizing data and merging into uniform templates
  • Other duties as assigned.

III. Position Requirements: Education or Equivalent: (Minimum required to perform job) Bachelor of science degree in related field.

Experience: 4-7 years of experience in the pharmaceutical industry preferably in Quality function

Knowledge/Skills Requirements:
  • High level of attention to detail.
  • Full complement of business computer literacy skills (e.g., word processing, spreadsheets, database software, etc.) is required.
  • Proficient in problem solving and analytical skills.
  • Proficient in technical investigations, batch record review and technical writing
  • Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
  • Review documentation for accuracy and completeness.
  • Strong computer and appropriate communication skills (both written and oral) allowing direct interaction with outside suppliers, RTP internal staff.
  • Should be familiar with cGMP and safe work practices.
  • Demonstrated ability to read, write, and speak clear English.

Physical Requirements:
  • Frequent sitting, walking, reading of written documents and use of computer monitor screen, writing, talking, carrying, listening
  • Occasional lifting and/or moving up to 30 pounds

Business Environment:
  • Fast-paced
  • Performance driven
  • Customer focused
  • Collaborative and inclusive

EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, 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 or

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