Responsible for organization and creation of department documents and assisting with all Quality Unit needs as they pertain to quality system compliance.
Reporting Relationships: Individual Contributor
- Plan, develop, organize, write, and edit department documents including but not limited to: stability protocols, stability reports, vendor qualification reports, and standard operating procedures.
- Create, collect, track, trend, and maintain testing data in the appropriate document.
- Maintain annual report tracking information for submission to Quality Assurance and Regulatory Affairs.
- Maintain inventory of offsite documentation.
- Maintain control of all laboratory notebooks, stability cards and laboratory documentation.
- Maintain laboratory inventories.
- Address all cross functional concerns with QC documentation.
- Perform data trending activities as assigned.
- Scan, copy, and file laboratory documents for customers or Regulatory Affairs as needed.
- Keep supervisor and manager informed of all key quality findings and issues.
- Other duties as assigned.
- BS degree in a science related field with 1-5 years of pharmaceutical industry experience.
- Demonstrated ability to work on multiple projects and meet timelines.
- Knowledge of cGMP requirements.
- Practical experience with document control, and QA support of manufacturing.
- Strong knowledge of Microsoft Word and Acrobat (PDF) documentation systems.
- Excellent organizational skills.
- Detail oriented.
- Collaborative working style. Demonstrates professionalism, cooperation and willingness to support team and company priorities.
- Strong interpersonal skills.
- Excellent written and oral communications.
- While performing the duties of this job, the employee is regularly required to stand. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs