Manufacturing Specialist – Aseptic

Responsibilities

• Perform data analysis, including tracking and trending of manufacturing processes to identify areas of improvement.
• Measure and evaluate unit operation durations to implement optimal scheduling to meet facility and client requirements.
• Author Change Controls to support investigations, process changes and equipment modifications.
• Author investigations and facilitate the closure of investigations on time.
• Review and approve new batch records as well as perform review of executed batch records.
• Provides training to manufacturing staff on operating procedures, batch records and GMP process rationale.
• Provides technical, on the floor support of commercial, clinical, and validated processes.
• Supports clients/stakeholders as a subject matter expert of commercial, clinical, and generic products.
• Evaluates product impact of process excursions outside proven acceptable ranges.
• Seeks opportunities to improve process performance within process ranges defined by large-scale equipment capabilities.
• Troubleshoots unexpected events during cGMP manufacturing, assists other departments in investigating and documenting process deviations and CAPAs.
• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA, OSHA, and DEA.
• Complies with all company and site policies and procedures.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Ensures operations are performed in a safe, clean, and organized work environment free of safety hazards.
• Other duties as assigned.

Qualifications

• Related bachelor’s degree preferred with 2+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Or applicants with high school or equivalent certification with 8+ years related experience in the manufacture of sterile injectable products in a regulated environment.
• Must have at least 1 year of experience in technical writing (deviations, SOPs, batch records, etc.).
• Must have demonstrated leadership and training experience.

Knowledge, Skills, And Abilities

• Ability to drive manufacturing operations and identify/improve inefficiencies.
• Ability to work with people at all levels of the organization.
• Ability to create and interpret graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.
• Ability to effectively present information and respond to questions from groups of managers and clients.
• Basic knowledge of computers and Microsoft Office software products.
• Applies job skills, company policies and SOPs to complete a variety of tasks.
• Receives general instructions on routine work, detailed instructions on new projects or assignments.