Quality Control Biochemistry Supervisor

Location
27713, Durham
Posted
Jan 14, 2019
Required Education
Bachelors Degree
Position Type
Full time

Under the supervision of the Director of Quality Control, the candidate is responsible for overseeing laboratory operations in support of cGMP compliant Biochemistry programs supporting manufacturing and stability. The candidate will work directly with external groups, labs, and vendors to ensure timely testing and compliant documentation in support of material and product release.  Responsibilities include the following:

Tasks/Responsibilities:

  • Manages ongoing day-to-day activities Biochemistry quality control programs and establishes/maintains testing schedules.
  • Establish and manage of quality control program standards, procedures, and services for biochemistry analysis in accordance with Medicago procedures and policies
  • Lead a team of QC Specialists engaged in laboratory operations for sample handling, storage, testing, and documentation activities supporting biochemical analysis to ensure high productivity, technical integrity, and compliance with GMP laboratory standards
  • Facilitate testing of in-process and product release to support production scheduling
  • Coordinate method validation/verification for in-house testing
  • Support testing for stability
  • Manage sample and documentation flow between buildings/labs
  • Investigate and document Out of Trend/Specification results
  • Review/Approve QC documents
  • Compile data and provide QC metrics and reports for program status and resource planning purposes
  • Provide timely and accurate reports and assessments of routine testing programs and assigned project(s) status
  • Act as subject matter expert for Biochemistry area during internal and external inspections

    Competencies:

  • Experience with cGMP manufacturing processes
  • Thorough knowledge of quality/regulatory system subject matter, ability to evaluate records, processes, procedures, and practices for conformance to cGMP requirements
  • Ability to lead guide and assist employees to reach scheduling and quality targets in a timely manner
  • Ability to solve problems to maintain efficiencies to meet demand
  • Problem-solving skills, attention to details, and basic data analysis skills
  • Excellent communication skills both written and oral required with demonstrated ability to create accurate, concise, and scientifically sound reports and communicate/interact with all levels of management
  • Ability to function independently, work in a fast-paced multitasking team environment, and meet critical timelines

    Education/experience:

  • Requires a Bachelors or Master’s degree in Biochemistry or other life science and a minimum of 7 years’ or equivalent of quality control experience in the biotechnology industry.     
  • A minimum of 2 years of direct supervisory experience in the biotechnology/pharmaceutical industry.