Documentation Specialist

Summary:
This position reports to the Manufacturing functional areas. This position provides the Manufacturing documentation review. Review the batch record or any other GMP document to ensure the compliance with cGMP, Company Policies and local SOPs.

Essential Duties and Responsibilities:
Supporting manufacturings batch documentation review.
Responsible for ensuring manufacturings 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.

Education and/or Experience:
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.