KNOWLEDGE SKILLS AND ABILITIES
- Basic knowledge of Document Control fundamentals, Quality Systems and GMP requirements
- Understanding role of QA and QC in an organization
- Ability to multitask and organize time efficiently
- Excellent attention to detail
- Works effectively with others as part of a team
EDUCATION AND/OR EXPERIENCE
- Proficient knowledge of Internal Auditing and Change Control practices in accordance with GMP requirements.
- Skilled at reporting metrics showing performance and trending; advanced data analysis skills a plus
- Ability to manage numerous priorities and activities in parallel (project management)
- 3 years of experience in Document Control
- Experience auditing to 21CFR preferred
- Ability to review current processes and implement productivity and compliance improvements
- Strong “people skills” to be able to deal with various personalities and levels within and outside of the organization
- Excellent verbal and written communication skills; ability to write reports and SOPs required.
- Excellent organizational skills and be detail oriented Knowledge of Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
CERTIFICATIONS, LICENSES, AND REGISTRATIONS
PHYSICAL DEMANDS AND WORK ENVIRONMENT
Subject to extended periods of sitting and/or standing, vision to monitor and moderate noise levels. Work is generally performed in an office environment.
JOB TITLE: QC Chemistry Coordinator/Document Control
FLSA STATUS: Exempt
REPORTS TO: QC Chemistry Laboratory Manager
The QC Chemistry Laboratory Coordinator/Document Controller will be responsible for assisting with the maintenance, issuance, and creation of chemistry laboratory Quality System documentation. He/she will provide administrative support to the Chemistry Quality Control lab to ensure that samples are received and results are reported correctly. Manages supplies and all documentation within the lab. Facilitates communication with other departments and outside services. Performs other administrative duties as assigned.
ESSENTIAL DUTIES AND RESPONSIBILITIES
· Manages contract laboratory test results.
· Receive samples and associated paperwork at the QC laboratory, log the samples into QC system, and store the samples properly.
· Assist in generating and revising GMP documents such as SOP.
· Review and periodically audit laboratory Quality Management System documentation (lab notebooks, forms, documents, certificates, etc.) verifying that records are complete and appropriate.
· Review routine laboratory data to ensure quality standards are met and to verify compliance with applicable SOP and regulatory requirements (GMP)
· Distribute samples to analysts for testing and control the sample flow at the QC lab.
· Dispose of samples properly after testing completion.
· Trends laboratory test data.
· Monitors inventory, places supply order prior to depletion, stocks and maintains laboratory supplies.
· Provides routine feedback to Laboratory Manager regarding assigned projects and other activities.
· Provides support in all regulatory inspections: FDA, DEA, Board of Pharmacy, and Internal Audits.