- Perform final review and determine acceptability of documentation concerning plant systems, processes, and finished product by using Standard Operating Procedures, Specifications and Master Documentation Manuals (MDMs).
- Responsible for performing batch release and expediting batch release to facilitate cost effective inventory.
- Review and comply with Good Documentation Practices.
- Plan own workload to release and review batch record documentation by priority.
- Perform final review of test results for completeness and assurance that product is within limits per specifications.
- Perform final review of production documents.
- Read Bill of Materials and temporary substitutions to assure correct parts have been used.
- Perform final review of sterilization charts, records, and graphs to assure product has been sterilized by the correct specifications and parameters.
- Ensure all support documents and correct signatures are present before releasing systems.
- Maintain files such that documents are readily available for area of responsibility.
- Ensure that documents removed from the area are corrected and returned in a timely manner.
- Accumulate all required documentation for a batch and perform cross checks on documents with a specific batch.
- Release batches in a timely manner.
- Resolve issues with supervisor to assure acceptability of product.
- Interact with peers, production and Quality Management at all levels.
- Perform all other duties and responsibilities as determined by supervision/management.
- High school degree required. Additional education or training desired.
- Two or more years of documentation experience required (or equivalent work experience.
- Strong computer proficiency, word processing, and proofreading skills are strongly desirable.
- General office skills required.
- General knowledge of environmental health and safety regulations for a plant environment are a plus.
- Ability to organize workload and prioritize tasks required.
- Strong communications skills with all levels of employees within the organization.
- Able to work with minimal supervision.
- Able to review and make decisions regarding Good Documentation Practices compliance.
- Must be able to work independently and within a team environment.
- Must be flexible.
- Low absenteeism.
- Must demonstrate sense of urgency.
- Must hold oneself accountable and meet deadlines.
- Strong oral and written communication skills required.
- Strong proficiency in computer skills.
- Able to lift up to 10 pounds.
- Able to lift above the shoulder up to 10 pounds.
- Able to bend/stoop/kneel.
- Able to climb ladders.
- Able to reach above shoulder.
- Able to sit and/or stand for long periods of time.
Equal Employment Opportunity
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.