Documentation Specialist - Katalyst Healthcares & Life Sciences
Round Lake, IL 60073
About the Job
Responsibilities and Requirements:
- Supporting manufacturing's batch documentation review.
- Responsible for ensuring manufacturing's batch records meet specifications and submitted to Quality per release schedule.
- Assure batch documentation complies with GDP standards.
- Determine acceptability by using specifications and standard operating procedures.
- Ensure presence of all required documentation prior to the submission of batch folder to Quality.
- Maintain files such that documents are readily available and easily retrievable.
- Initiate and close GME work orders.
- Author Non-Conformance Records (NCRs) and Exceptions Investigations.
- Author TCU documentation changes including revisions, periodic reviews and GAP assessments.
- Use Maximo system to print department preventative maintenance work orders; assign and bring to completion, as necessary.
- Use SYSTECH to review and approve counts for batches.
- Initiate batch folders by performing necessary data entry.
- Support GME cycle counting as needed.
- Other administrative duties as assigned.
- Qualifications: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
- Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
- Strong computer skills in MS Office Suite.
- Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
- Strong attention to detail.
- Individual will work with minimal supervision in a dynamic environment while following written procedures.
- Must be organized and able to prioritize tasks.
- Ability to communicate efficiently verbally and in writing with all levels of the organization.
- Identify areas for continuous improvement.
- Individual must be willing to adjust work hours and work overtime based on business needs.
- Must be able to lift 30 pounds.
- Must not be allergic to Penicillin or Cephalosporin drugs.
- Include the education and experience that is necessary to perform the job satisfactorily.
- Associates degree or 3+ years of experience in manufacturing environment and / or quality documentation.
Source : Katalyst Healthcares & Life Sciences