Manufacturing Documentation Specialist

Title: Manufacturing Documentation Specialist
Full Time/Part Time: Full Time
Location: Pleasant Prairie, WI
Our Company
Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they're needed most.
Summary
Nexus Pharmaceuticals is hiring for a Manufacturing Documentation Specialist. The candidate must be familiar with applicable cGMP regulations, formulation, aseptic fill.
Responsibilities:

• Own and implement continuous improvement initiatives
• Maintain advanced knowledge of the manufacturing systems
• Review manufacturing batch records and recommend changes as necessary
• Support Training Initiatives
• Own manufacturing deviations/CAPAs
• Contribute to performance metrics for Quality/Compliance related topics, such as deviations, CAPAs, effectiveness checks
• Contribute to audit/regulatory agency observation responses, including tracking of timelines, status, and completion
• Work with quality, validation, and maintenance to facilitate, coordinate, or participate in MFG support for inspections
• Participate in investigations, including determination of root cause and evaluation, initiation, and ownership of CAPA's
• Redline and/or create Standard Operating Procedures and FMEA to support manufacturing
• Conduct/support internal and external audits
• Participate in inspection readiness activities and significantly involved in inspections by regulatory authorities (FDA/DEA)
• Other duties as assigned

Skills and Abilities:

• Specific skill set: critical thinking, technical writing, problem solving, experience in investigative techniques, highly detail oriented, and highly organized
• Knowledge of Microsoft Office Suite required

Education and Experience:

• Minimum 5 years' experience in the pharmaceutical industry
• Bachelor's degree required in Chemistry, Biology, Engineering, Science or Business or related field

Travel Requirements:

• 15-20% travel required for this role

Physical Requirements:

• Lifting requirements less than 50 pounds
• Sitting 85% of day
• Manufacturing environment

DISCLAIMER: The list under Role Responsibilities is not exhaustive, but is merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change.
EEOC Statement: Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.