Lead QC Associate I (Chemistry)
FujiFilm Diosynth Biotechnologies - Durham, NC

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Job Description:
In this position, the successful candidate will be a
part of the Quality Control function that supports the
manufacturing operations. The incumbent is expected to
come in with a very sound background in protein
chemistry and chromatography. Chemistry disciplines
common to the laboratory include, but are not limited
to: RP-HPLC, SEC-HPLC, IEX-HPLC, Peptide Mapping, DNA
Threshold. Individuals in this role are expected to have
strong proficiency within the assigned disciplines as
well as GMPs.

Main areas of responsibility include:
  • Schedules, plans and executes multiple HPLC assays a
day to support routine and non-routine manufacturing
support according to established scheduling and
communication tools.
  • Supports Chemistry testing such as HPLC and DNA
Threshold, and other related methodology according to
standard procedures.
  • Ability to effectively communicate using visible
management tools, such as task assignment and scheduling
boards.
  • Initiates statistical review of relevant data e.g.
product / complaint trends, laboratory test results,
stability profiles, etc. as data is reviewed
  • Capable of effective troubleshooting equipment and
method issues as necessary
  • Assures accurate and compliant documentation of cGMP
activities
  • Participates in the laboratory internal auditing
program
  • Leads laboratory investigations and deviation
resolution for atypical or OOS events to satisfactory
conclusion
  • Capable of contributing to a Right First Time, high
throughput work environment.
  • Provides as-needed testing support for the laboratory
operations during off-shift hours in support of the
established supply schedules.
  • Actively participates in the validation,
qualification, or technical transfer of
chemistry-related methods into Quality Control, either
from Analytical Development or directly from the client.
  • Leads the laboratory testing activities during method
transfer/qualification/validation: develops experimental
design based on existing protocols, conducts testing,
authors Test Methods and Data Forms,communicates status
of project to Tech Experts and Management, and escalates
issues when appropriate. Owns the methods from start to
finish, from initial feasibility to GMP execution
First Shift (Monday-Friday)

Job Requirements:
Job Requirements

Minimum Requirements: Education, Experience and Skills:
  • BS/BA in a science field, preferably chemistry,
biological sciences or related field
  • Minimum 6 years of relevant GMP lab experience or an
equivalent combination of education and skill sets
  • Demonstrated knowledge of the Waters Empower
software
  • Thorough understanding of Chromatography from column
chemistry and peak integration to HPLC plumbing and
operation
  • Demonstrated interpersonal, technical, and
problem-solving skills
  • Must be flexible, able to manage several assigned
tasks, and work independently with minimal oversight
  • Must have attention to detail, good documentation
skills, and ability to communicate with peers and
colleagues within and outside of the department
  • GMP experience
  • Demonstrated ability to execute chromatography-based
method validations, qualifications, and tech
transfers.

FujiFilm Diosynth Biotechnologies - 16 months ago - save job - block
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