USA - Documentation Specialist

Job DescriptionSummary: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 scheduleAssure 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 InvestigationsAuthor TCU documentation changes including revisions, periodic reviews and GAP assessmentsUse 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 neededOther 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. Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@, @planet-pharma.co.uk, and @) and not a domain with an alternative extension like .net, .org or .jobs.

Created: 2026-04-02