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QA Operations Specialist (cGMP – Pharmaceutical) JD817774

JD817774

DPS is seeking an established and knowledgeable Quality Specialist to work with a BioPharma client in the Boston, MA area. Successful candidates should have previous experience working with other departments to ensure the quality of products and compliance to internal procedures and external standards. This individual will review records as well as develop and improve quality system procedures, specifications, and test methods.

Category:
Quality
Location:
Massachusetts
Years of Experience Req.:
3+
Date Posted:
15/06/2019
Days Remaining:
19
Employment Type:
Full-time
Education Level Req.:
Bachelors

QA Operations Specialist (cGMP – Pharmaceutical)          JD817774

Boston, MA area

 

DPS is seeking an established and knowledgeable Quality Specialist to work with a BioPharma client in the Boston, MA area.  Successful candidates should have previous experience working with other departments to ensure the quality of products and compliance to internal procedures and external standards. This individual will review records as well as develop and improve quality system procedures, specifications, and test methods. 

 

Responsibilities:

  • Maintain and continuously improve quality system processes and procedures.
  • Review documentation supporting GMP activities for accuracy and completeness.
  • Release Batch Records and labeling for manufacturing.
  • Review executed Batch Records and associated test results.
  • Coordinate or perform investigations of quality issues and product complaints and implement corrective/preventive actions.
  • Review change controls and validation documentation.
  • Assist with internal audits and supplier audits as needed.
  • Monitor performance of quality systems and generate reports to communicate status to management.

 

Qualifications & Experience:

  • Bachelor’s Degree in Science or related technical field.
  • 3+ years’ of experience in pharmaceutical, biotech or medical device industry.
  • Excellent organiz660106.763006ational skills and attention to detail.
  • Good verbal and written communication skills.
  • Strong interpersonal skills and ability to work efficiently on a team.
  • Ability to make decisions and resolve issues with minimal guidance.
  • Knowledge of FDA and international regulations and GxP guidelines.
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