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.

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The Supervisor, Visual Inspection is accountable for driving results in a fast-paced environment by leading daily manufacturing operations for visual inspections. The Supervisor, Visual Inspection drives the performance and engagement of Visual Inspection Technicians who perform the inspection of liquid/lyophilized vials and syringes. This leader is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and driving performance management, training/development and continuous improvement of the team. In addition to overseeing manufacturing personnel, this hands-on leader should have functional capability to perform the essential functions and activities alongside the Visual Inspection Technicians as necessary.

• 100% on-site position.
• 1st Shift: Monday - Friday, 7:00am - 3:30pm.
• Shifts may include weekends and holidays to support operations as necessary.

• The primary role is to schedule and drive the execution for visual inspection of syringes, liquid vials and lyophilized products to ensure product quality is maintained through identification of potential defects or discrepancies in product appearance and container integrity.
• Follow established Standard Operating Procedures (SOPs) and cGMPs to execute protocols and procedures for visual inspection, ensuring compliance with regulatory requirements and company standards.
• Promote continuous improvement through ownership and authoring of SOPs and Batch Record Forms.
• Investigate manufacturing/inspection discrepancies and own Corrective/Preventative Actions.
• Conduct visual inspection training to support employee qualification, and to ensure consistent and accurate inspection practices across manufacturing shifts.
• Maintain defect kits and defect libraries to support process qualification and general improvement.
• Perform batch record review to support timely batch release.
• Track and manage product hold times and finished product storage conditions to ensure product quality is maintained.
• Perform product risk assessments to evaluate conformity with existing visual inspection qualification process.
• Manage external eye examination contracts to support annual qualification.
• Track and trend visual inspection defect data throughout manufacturing and provide annual summary reports.
• Sample and package finished product batches for further testing and analysis, ensuring proper documentation and labeling.
• Ensure unit accountability is maintained throughout inspection/manufacturing operations and provide batch yield reports to management.
• Manage inventory of batch consumables and finish product samples, retains and acceptable units for further processing using electronic management systems.
• Coordinate material transfer with off-site warehouse team for inventory control.
• Support area sanitization and product dispensing, as necessary.
• Provide general support for dispensing, compounding, and isolator filling operations within Grade C/D environments to assist operations in varying capacities.
• Support operations through area sanitization, equipment preparation, and performing in-process testing such as pH testing, glove/filter integrity testing, etc.
• Collaborate with cross functional teams to address quality related issues and implement process improvements.
• Other duties as assigned.

• High school diploma or GED with applicable experience; bachelor’s degree preferred.
• 2-4+ years’ applicable work experience required.
• cGMP or prior work experience in a Pharmaceutical regulated manufacturing environment required.
• Previous experience in visual inspection of syringes, liquid vials or lyophilized products is highly desirable.

• General knowledge of current Good Documentation Practices (GDP) and ability to legibly document activities performed in real time per area SOPs.
• Familiarity with PDA Technical Report No. 43 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 detect minute defects or discrepancies in product appearance.
• Excellent communication and interpersonal skills, with the ability to effectively train and certify employees.
• 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 a plus.

• Up to 5% domestic travel.

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 accommodations 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. The employee must have 20/20 vision (with or without corrective lenses) and must possess the ability to pass a color-blind test.

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. The use of tight-fitting respirators limits facial hair for proper protection. Based on product, the use of PAPR or supplied air respirator may be required. Regulations may require employees to participate in routine medical surveillance.