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QC Compliance and Data Integrity

Location: 

Ormond Beach, FL, US

Req ID:  401
Job Type: 

We are a global team of 6,000 visionaries, doers, and makers. Our portfolio of over 25 brands touches lives in more than 50 countries. Together, we reimagine good mornings and endless summers, beauty and bonding, confidence and determination.

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. 

 

Universal Accountabilities

  • Follow cGMP and 21CFR 210 and 211 requirements for laboratory testing and investigations.
  • Review notebooks, forms, raw data, and audit trails
  • Review protocols and reports that pertain to the QC Laboratory
  • Collaborate with internal and cross functional colleagues as needed
  • Manage material flow in conjunction with Planning and Scheduling.
  • Follow SOPs and test methods.
  • Support laboratory management in OOS investigations. Compiles 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
  • Reviewing applicable compendia for upcoming changes that may affect the OB QC Lab
  • Train new laboratory technicians
  • Organize and maintain laboratory documentation such as system suitability, protocols, validations, and investigations

Specific Accountabilities

  • Perform job duties in a compliant and safe manner
  • Adhere to testing and projects 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.

 

Required Skills and Experience

  • 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 Chromeleon, spreadsheets.
  • Must be willing to occasionally work OT as needed.
  • 40 to 1+ years of experience working in a cGMP environmentlaboratory

 

Preferred Skills and Experience

 

 

Working Relationships

  • Internal contacts: Cross-functional team (Purchasing, Operations, Quality, R&D, Engineering, Human Resources, technical support groups) as well as other value streams.
  • External contacts:  Suppliers as needed or directed by laboratory management.

 

Work Environment

  • Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
  • Work schedules that vary from typical business hours.
  • Exposure to health risks or conditions that may require the use of Personal Protective Equipment.

 

Environmental, Health and Safety Responsibilities

  • Conform to safety regulations and procedures to maintain a safe working environment.
  • Be aware of and follow the Environmental Policy and EH&S work instructions/procedures that apply to the job.
  • Performing every job safely, for the benefit of self, co-workers, contractors, and for the protection of facilities.  This includes the use of required personal protective equipment and use of safely equipment/devices, guarding, as well as safe work practices.
  • Immediately reporting every job-related injury or illness, regardless of severity, to a team leader/supervisor
  • Assist in investigating incidents.
  • Taking necessary actions to correct or stop unsafe conditions or practices.
  • Actively participation in safety meeting and training.
  • Review SDS instructions before working with any chemicals or hazardous materials.

 

Quality Responsibilities

  • Colleagues are responsible for their own quality and that of colleagues within their span of control.
  • Colleagues are responsible to follow all established Quality procedures and instructions.
  • Colleagues are responsible for notifying leadership for corrective action if defects are found and/or parts/processes do not conform to specifications.
  • Colleagues are responsible for adhering to current Good Manufacturing Practices (cGMP) work rules as they relate to job-specific duties.

 

Supplemental Information

  • This description is based on management’s assessment of the requirements and functions of the job as of the date this description was prepared. It is a general guideline for managers and employees, but it does not purport to be an exhaustive list of all the elements of the job.  Management reserves the right to modify and description at any time, or to vary the duties and responsibilities of the job on a temporary or indefinite basis to meet the production, scheduling, or staffing needs.

 

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Edgewell is an equal opportunity employer, and 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 other legally protected status in accordance with applicable federal, state and local laws.


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