Share this Job

Quality Control Technical Writer

Location: 

Ormond Beach, FL, US

Req ID:  2902
Job Type: 
Edgewell is a global team of over 6,000 visionaries, doers and makers. Our secret is people, and we have an inspiring and collaborative global force of them. Our portfolio of over 25 brands touches lives in more than 50 countries by making useful things joyful. Together, we reimagine good mornings and endless summers, strive for more sustainable ways to beautify and bond, and do it all with not only confidence but determination.

POSITION SUMMARY:

Work in a cGMP environment ensuring the data generated in the Quality Control Laboratory meets cGMP, USP, and good documentation requirements. Work on routine and non-routine laboratory projects as directed by Quality Laboratory Management Team. 

 

ESSENTIAL FUNCTIONS:

  • Follow cGMP and 21CFR 210 and 211 requirements for laboratory testing and investigations.
  • Write or Review protocols and reports that pertain to the QC Laboratory
  • Support laboratory management team in OOS investigations. Compile data and participate in different steps of the investigation process.
  • Must be willing to work overtime as needed.
  • Work on non-routine projects as directed by the laboratory supervisor
  • Organize and maintain laboratory documentation such as system suitability, protocols, validations, and investigations
  • Able to interact effectively at various levels within the organization and other external contacts
  • Able to quickly learn complex business processes and specialized terminology
  • Able to work in a changing environment with changing priorities

 

OTHER DUTIES AND RESPONSIBILITIES

  • Perform job duties in a compliant and safe manner
  • Adhere to testing and project deadlines as assigned by quality laboratory management
  • Escalate non-conformances and Out of Specification results in a timely manner and in accordance to local and corporate procedures.

 

EDUCATION AND EXPERIENCE

  • Associate degree or B.S. or B.A – Science or Engineering Degree
  • Minimum 2 years of experience in a QC laboratory or equivalent.
  • Must be able to work with minimum supervision.
  • Effective verbal / written communication, interpersonal, and team-building skills.
  • Excellent organizational, problem-solving, prioritizing and follow-up skills.
  • Ability to handle multiple tasks / projects simultaneously.
  • Good computer skills. Proficiency with Microsoft Word, Excel, and Power Point.
  • Must be able to learn and work with computer software such as SAP, Chromatography software, spreadsheets.
  • Must be willing to occasionally work OT as needed.
  • 4+ years of experience working in a cGMP environment
  • Experience working in an FDA regulated laboratory.
  • Working knowledge of SAP, a plus.
  • Working knowledge of FDA 21 CFR part 210 and 211 requirements.
  • Working knowledge of Empower a plus.
  • Data Integrity knowledge

#LI-JM1

Edgewell is an equal opportunity employer. We do all we can to create a collaborative and diverse global team, where good ideas can thrive, and our colleagues can learn and lead. We prohibit discrimination based on age, color, disability, marital or parental status, national origin, race, religion, sex, sexual orientation, gender identity, veteran status or any legally protected status in accordance with applicable federal, state and local laws. We listen deeply and speak directly to create an environment that’s open to difference. We aim to bring joy to not only the products we create and the people we serve, but our colleagues across the globe too.