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R_ Quality Specialist I

Date: Jul 3, 2019

Location: Coventry, RI, US, 02816

Company: Purdue Pharma L.P. & Affiliates

Job Summary

Analyze raw materials, in-process, and finished products assuring compliance with company  standards and applicable government regulations. Work closely with R&D analytical development to ensure a smooth transfer of methods.

Primary Responsibilities

 

 

 

  • Perform qualitative and quantitative testing on routine and non-routine samples using technique analytical equipment to highly sophisticated and automated instrumentation.
  • Quality work and quality notebooks are expected when as part of documentation requirements.
  • Review raw data and results of other chemists and laboratory technicians in timely manner.
  • Fundamentally understand and use applicable quality systems.
  • Maintain all accurate regulatory documentation.
  • Collect data ensure compliance  with applicable cGMP, GLP, DEA regulations and internal Standard Operating Procedures (SOPs).
  • Maintain current knowledge base within relevant technical discipline of FDA regulations and awareness of the necessity and impact of compliance on the business.
  • Maintain current knowledge base in relevant technical discipline.
  • This position requires the ability to work closely with analytical R&D, manufacturing, and QA to resolve issues related to method transfer and manufacturing.

  • With supervision, performs day-to-day functions of the position, such as processing, tracking, controlling, routing and maintaining documents, items, samples, etc.
  • Identifies cGMP issues and prepares reports for management.
  • Consults with supervisor / management on decisions for all issues.
  • Work is closely supervised. Follows specific, detailed instructions and standard operating procedures.
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  • Timely follow-up on goals to ensure progress.

 

Education and Experience
  • BS/MS with 1 year minimum of experience or equivalent level of experience in pharmaceutical or related industries.
Necessary Knowledge, Skills, and Abilities
  • With supervision, performs day-to-day functions of the position, such as processing, tracking, controlling, routing and maintaining documents, items, samples, etc.
  • Identifies cGMP issues and prepares reports for management.
  • Consults with supervisor / management on decisions for all issues.
  • Timely follow-up on goals to ensure progress.
  • Work is closely supervised. Follows specific, detailed instructions and standard operating procedures.
  • Demonstrated basic understanding, knowledge and ability in primary discipline.
  • Recognizes problems or compliance issues and reports to manager. May propose ideas for resolution.
  • Demonstrated knowledge of basic concepts, principles and techniques for executing SOPs.
  • Maintains written and properly signed records of work actively.
  • Maintains tracking documents for status of issues in job function.
Supervisory Responsibilities (if Applicable)

N/A

Additional Information

Rhodes Pharmaceuticals is committed to our customers.  We achieve our mission through our people who are our strength, who are relentless and possess a passion for providing quality products to meet the needs of patients.


Nearest Major Market: Providence
Nearest Secondary Market: Rhode Island

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