QCC Technical Documentation Specialist

4 weeks ago

Lexington, United States Kindeva Drug Delivery Full time
Job Details

Level
Experienced

Job Location
Company Headquarters - Lexington, KY

Position Type
Full Time

Education Level
4 Year Degree

Job Category
QA - Quality Control

Description

Summary:

This individual is responsible for supporting quality compliance within the QCC group, ensuring quality events and other documents are tracked and closed in a timely manner, including CAPA, SOP updates and audit responses, keeping management informed on quality issues.

Essential Duties:

  • Work in a safe manner in accordance with site procedures
  • Support quality event writing and closure, both as lead writer and as supporting or reviewing roles
  • Perform compendial reviews
  • Write, revise and review Standard Operating Procedures, Material Specifications, Forms, Protocols and Reports
  • Troubleshoot and recommend process improvements to reduce level of quality events
  • Recommend and implement, as required, innovative approaches to problem solving
  • Prepare and present study or evaluation summaries as needed
  • Manage time effectively
  • Support process improvement initiatives, from participation to project lead
  • Mentor Chemist I, II and III
  • Review and approve data
  • Other duties as assigned
Knowledge, skills and abilities:
  • Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules
  • Team player with well-developed interpersonal, organizational, and communication skills
  • Experience as primary author for quality events
  • Ability to handle stressful situations
  • Understanding of current Good Manufacturing Practices (cGMPs) with a focus on quality
  • Good method validation knowledge
  • Good instrument qualification knowledge
  • Excellent investigative skills for OOS, OOT and aberrant result laboratory investigations
  • Excellent oral and written communication skills.
  • Knowledge of data acquisition systems such as Empower CDS
Qualifications
  • Bachelor's in Chemistry or related field with at least 6 years pharmaceutical industry experience
  • Knowledge of cGMP and ICH regulatory requirements
  • Good interpersonal skills and the ability to work well in a team environment
  • Enthusiasm for building a company with outstanding work ethic; must be able to perform in a fast-paced multiproduct environment
  • Qualified to work with controlled substances

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