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Quality Control Analyst III

Rentschler Biopharma Inc.
Milford, MA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

Job Summary

 As a key member of the Quality Control team, the QC Analyst III is responsible to perform QC related technical writing associated with QC activities, investigations, CCRs, and CAPAs to ensure compliance based on regulatory and industry standards.  The role will include performing site System Administrator rights for all QC electronic systems.

 

Duties and Responsibilities

  • Write, review & revise SOPs reports, protocols & other appropriate documentation for proper functioning of lab operations.
  • Independently conduct and document laboratory investigations and CAPA implementations.
  • Work on special projects / protocol testing that involves new methods and instrumentation. 
  • Serve as mentor to other Quality Laboratory positions as needed. Provide training and work direction for group members as required.
  • Assist in implementing quality & regulatory requirements (e.g., FDA, GLP, cGMP, USP, Ph. Eur., & CFR rules/guidelines).  
  • Drive and participate in continuous improvement initiatives that impact production, increase efficiency, solve problems, generate cost savings, improve quality & provide new product support.
  • Perform review of test data, which includes overall documentation practices. Review data in LIMS.
  • Review validations for laboratory instruments and methods.
  • System administrator for QC equipment/instruments and systems.
  • Participate in internal laboratory audits as required.
  • Technical writing as needed

 

Qualifications

  • Bachelor’s Degree in a biological science with minimum of 5 years of related experience (or master’s degree in a biological science with 1-4 years of experience) in a CGMP environment   
  • Strong leadership, organizational and time management skills.  Clear ability to organize and prioritize work schedule in order to meet deadlines.
  • Must be able to communicate effectively with managers and peers.  Must possess ability to foresee and communicate bottlenecks that impede completion of tasks in a timely manner.
  • Must demonstrate effectiveness in ability to train others as needed.
  • Strong knowledge and expertise of quality/regulatory requirements pertinent to pharmaceutical QC labs.
  • Strong working knowledge of laboratory safety including standard precautions associated with hazardous & biohazardous material handling.
  • Experience with electronic QC systems and software, as well as general knowledge/understanding of 21 CFR part 11 is required.  Laboratory testing experience is highly desirable. 
  • Computers skills to include full competence with Microsoft Word, Power Point & Excel and LIMS is required.
  • Good communications skills – written and verbal
  • Proficient in Microsoft Office – Outlook, Word, Excel, PowerPoint

 

Working Conditions

  • Laboratory environment working with chemical reagents and analytical equipment 
  • Normal office working conditions: computer, phone, files, fax, copier.
  • Personal Protective Equipment must be worn as required
  • Minimum travel required (occasional international travel to support CMO investigations). 

 

Physical Requirements

  • Frequent lifting up to 10 lbs.; frequent standing/walking.
  • Manual and visual dexterity required to perform laboratory and computer tasks for prolonged periods.   
  • PPE as required

Rentschler Biopharma Inc.

Address

Milford, MA
01757 USA

Industry

Manufacturing

View all jobs at Rentschler Biopharma Inc.