Manufacturing Specialist – Visual Inspection / Training Coordinator

Alcami Corporation

  • Morrisville, NC
  • Permanent
  • Full-time
  • 1 month ago
:At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.Are you interested in joining our team? Job Summary:The Manufacturing Specialist is accountable for driving continuous improvement of the Manufacturing operations, focused on People, Process and the Tools & Technology that drive continuous improvement. The environment is fast-paced and demands consistent results. Efforts are focused on all aspects of Aseptic Operations Dispensing, Compounding, Aseptic Filling via isolator technology and Visual Inspection. The Specialists will be the Manufacturing subject matter expert (SME) for focused areas of responsibility. They will also cross-train in various areas to expand operational proficiency to optimize overall process knowledge and support of operations. They will support operations through root cause investigations of Manufacturing related deviations, CAPA implementation and associated actions to support the Right First Time manufacture and batch release of critical clinical/commercial products. This SME is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and works closely with the Manufacturing Leadership team, Technical Services, Quality Assurance, Engineering, and Supply Chain to ensure robust manufacturing of cGMP Sterile Injectable products. In addition to supporting manufacturing personnel, this hands-on SME should have a functional capability to perform the essential functions and activities alongside the Technicians, as necessary. On-Site Expectations:
  • 100% on-site position.
  • 1st Shift: Monday - Friday, 8:00am - 5:00pm.
  • Shifts may include weekends and holidays to support operations, as necessary.
Responsibilities:
  • The primary role is to support manufacturing readiness and drive proactive process improvement through the creation and maintenance of cGMP production documentation, SOPs, and Risk Assessments.
  • Follow established Standard Operating Procedures (SOPs) and cGMPs to execute protocols and procedures, ensuring compliance with regulatory requirements and company standards.
  • Troubleshoot and investigate manufacturing discrepancies related to focus areas to identify root cause, utilizing investigative tools such as After-Action Reviews (AARs), 6M methodologies, fish-bone, etc. The specialist will lead Corrective/Preventative Actions through on-time implementation.
  • Evaluate potential product impact of process excursions with support from Technical Services and Quality Assurance personnel.
  • Author Change Controls to support process compliance, general improvement, and drive timely completion.
  • Support the sample management program through notification of sample pick-up and readiness.
  • Perform timely batch issuance requests and identify manufacturing/support related material needs.
  • Conduct training to support various employee qualifications, and to ensure consistent and accurate manufacturing practices are implemented across manufacturing shifts for focus area.
  • Perform necessary activities to support timely batch release.
  • Utilize Subject Matter Expertise to support client/regulatory audit requests, including site tours, assist Project Management and provide pre/post-production batch related support to clients.
  • Carries out duties in compliance with all state/federal regulations (FDA, EPA, OSHA and DEA).
  • Provide technical on-the-floor support for dispensing, compounding, isolator filling, and/or visual inspection operations within controlled environments to assist Manufacturing supervision/management in varying capacities per focus area.
  • Author annual reports, as necessary, for tracking and trending of manufacturing operations to report general process capabilities and identify areas of improvement.
  • Define expected qualification timelines for compounding, filling and visual inspection focus roles, and identify cross training opportunities to support manufacturing readiness and redundancy.
  • Track Technician training progression for Manufacturing and Visual Inspection Technicians to ensure personnel expand operational capabilities to support routine production and personal development in alignment with Milestone expectations.
  • Coordinate, schedule, and source materials to execute hands-on training activities for dispensing, compounding, filling and visual inspection operations.
  • Support the execution for visual inspection of syringes, liquid vials and lyophilized products to ensure product quality and accountability is maintained through identification of potential defects or discrepancies in product appearance and container integrity.
  • Optimize visual inspection processes through identification of potential procedural inefficiencies and continuous improvement through SOP, defect library, and batch documentation ownership.
  • Utilize SAP for finished product inventory management.
  • Support warehouse personnel and sample coordinators to maintain and organize in-process/finished product samples and finished product prior to shipment internally or externally.
  • Ensure finished product and samples are stored in the correct conditions and support storage excursion response/remediation for 2-8°C, -20°C, and -80°C stored API, BDS or finished product.
  • Supports Manufacturing during critical operations and transformation changes to the process.
  • 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:
  • Ideal candidates possess practical and analytical problem solving skills and strategically manage discrepancies in alignment with SOPs and client interest.
  • Strong knowledge of current Good Documentation Practices (GDP) required.
  • Familiarity with USP guidance Annex 1 is highly desirable.
  • Experience with any of the following equipment is highly desirable:
  • Light inspection booths, light meters, and TAPPI charts
  • Filter integrity testers, steam sterilizers (autoclaves)
  • General compounding equipment (pH meters, mixers, stir plates, rigid/soft vessels)
  • Single-use solution pathway parts including aseptic connectors and filtration assemblies
  • Drug Product fillers including isolators
  • Strong attention to detail and the ability to identify and proceduralize processes intended to implement functional layers of control to support the manufacturing of high-quality products through routine operations.
  • Excellent communication and interpersonal skills, with the ability to effectively train and certify employees in a functional area of expertise.
  • Ability to effectively present information and respond to questions from management and clients to inform or support new or existing operations.
  • Ability to work independently and collaboratively in a fast-paced environment.
  • Flexibility to adapt to changing priorities and support operations at variable capacities. Ideal candidates must readily adapt to variable operations required batch to batch.
  • Basic computer skills (Microsoft Office) and familiarity with electronic documentation systems is required.
  • Receives general instructions on routine work and escalates potential questions/concerns to management in a timely manner.
Travel Expectations:
  • Up to 5% travel required.
Physical Demands and Work Environment:The physical demands and work environment characteristics described here are representative of those that must be met or encountered by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; talk or hear and smell. The employee is frequently required to walk; climb or balance and stoop, kneel, crouch, or crawl. The employee is occasionally required to sit. The employee must regularly lift and/or move up to 25 pounds, frequently lift and/or move up to 50 pounds, occasionally lift and/or move up to 75 pounds and occasionally lift and/or move over 75 pounds with assistance. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus. Occasionally, employees may be exposed to airborne particles, fumes or chemicals, therefore the ability to wear necessary PPE including PAPR is required. Employees occasionally may be required to moving mechanical parts and vibration.While performing the duties of this job, the employee is frequently exposed to moving mechanical parts, fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; risk of electrical shock and vibration. The noise level in the work environment is usually moderate. The employee will be required to wear the appropriate personal protective equipment for specific job duties to be performed. Such personal protective equipment may include, but not limited to safety eyewear, hearing protection, various types of respirators/breathing apparatus, lab coats, full protective body coverings, various types of gloves, etc. Based on products, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance.

Alcami Corporation