Manage document control activities, including but not limited to, Certificates of Analyses, Certificates of Compliance, deviations, change control, training, and maintenance of documents and reports. Track, scan, archive, and manage controlled quality documents and quality records, including training matrices and records, forms, specifications, stability reports and batch records. Support training and documentation activities for GLP and GCP activities also. Archive regulatory supportive R&D reports.Essential Functions
Knowledge and Competencies
- Manage document control, deviations and change control and training processes for GXP activities.
- Support audit scheduling and records for all GXP activities.
- Prepare and handle documents and procedures for review, approval, and execution.
- Develop, review and revise documentation procedures.
- Establish and maintain records management process including scan, storage, archival and retention.
- Support deviation and change control activities to ensure timely approval and closure.
- Oversee on boarding and on-going training program, tracking and maintaining training records
- Perform other duties, as assigned.
- Knowledge of GXP and GDP regulatory requirements.
- Self-motivated, excellent organizational skills, and ability to prioritize effectively.
- Ability to work and make decisions independently and as part of a team.
- Strong and effective verbal, interpersonal, and written communication skills.
- Strong collaboration, strategic thinking, leadership, and teamwork skills.
- Advanced computer skills.
- Preference- EDMS experience (Veeva Vault experience preferred).
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.
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to finger, handle, or feel. The employee is occasionally required to stand, walk, and reach with hands and arms. The employee must occasionally lift and/or move up to 10 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus in order to read.Work Environment
The work environment characteristics are representative of those an employee encounters while performing the essential functions of this job, typically in an open office environment. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The noise level in the work environment is usually moderate.
May be required to travel by plane or car
This position requires working with biological and/or chemical hazardsRequirementsQualificationsEducation & Experience
- Minimum, Bachelor's Degree in scientific discipline (Chemistry, Biology, Bioengineering, etc.).
- Minimum, 5 years of relevant bio-pharmaceutical industry experience, with a minimum 2 years of document management role.
All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.