The Aseptic Production Technician will be responsible for conducting cGMP manufacturing of sterile pharmaceutical dosage forms for commercial manufacturing. Under the direction of the Production Supervisor, the Aseptic Production Technician will work hands on, under ISO7 and ISO5 area, with a variety of manufacturing production equipment and technologies. Daily responsibilities vary and include production equipment set up, weighing of materials, manufacturing of batches, sterilization of product, submitting samples, performing filling operations under ISO5 environment.
Position Responsibilities Ensures that all work is carried out in compliance with company Safety Policies, Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs). Knowledge of current Good Manufacturing Practices (GXP) guidelines. Gowning up to 10 hours per day- 4 days per week. Gowning/Aseptic Technique Experience Reports any accidents, incidents and injuries or illnesses immediately and notifies manager of any hazards, unsafe acts or conditions in the workplace Prepares for production run by reviewing the production schedule; identifying batch specific requirements; weighing and measuring ingredients and adding to mixing equipment. Updates job knowledge by participating in training opportunities. Takes ownership for individual training plan. Responsible to review all documentation including Batch records and Logbooks in Real Time and Right First Time and demonstrate error free documentations. Immediately reports any error or deviations noticed to management.
Obtaining equipment and raw material for manufacturing and compounding. Follows all steps outlined in batch records. Ability to perform a batch record review in real time. Operation of Autoclave. Perform in-process filling checks and verification. Obtain Filling accessories.
Qualifications High School diploma with 3 years -Pharma/Biotech Manufacturing Support and 1 year- within Clean Room environments and some technical certification is desired in related field. Demonstrated ability to successfully gown into aseptic manufacturing areas. Excellent organization and time-management skills required. Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure. Must possess technical knowledge to operate and troubleshoot all operating equipment with minimal help. Environmental Monitoring, Water and product sampling. Fluent in English both written and spoken. Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed. Works with a sense of urgency, while engaging and listening to experts. Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills. Strong organizational skills with the proven ability to prioritize. Must be dependable and punctual. Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word Ability to handle sensitive information with a high degree of confidentiality. Must be able to work 2nd shift 1pm-9:30pm. Training will be on first shift 7am-3:30pm for 2 months.
- Customer/Client Focus.
- Ethical Conduct respect for others and solidarity.
- Technical Capacity to operate and troubleshoot processing equipment.
- Conscientiousness for work and documentation.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation can be made to enable people with disabilities to perform the described essential functions. While performing the duties of this job, the employee is regularly required to communicate effectively. The ability to see distinctions in colors and shapes is also required. This position is moderately active and requires standing and walking for the duration of the shift. There is a high frequency of reaching over your head and bending down throughout the duration of each shift. Work Environment
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the job holder will encounter. Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.
This job operates in a health care setting. This position requires frequent standing and walking to storage shelves and filling counters to fill prescriptions. While performing the duties of this role, the employee will be exposed to light, noise and ability to lift to 50lbs.
AAP/EEO Statement Imprimis believes in creating long-term relationships by being responsive and relevant and by consistently delivering value to our community of customers. Specifically, with our employees, we focus on attracting, developing and retaining the best talent for our business, challenging our people, demonstrating a can-do attitude and fostering a collaborative and mutually supportive environment. Diversity creates a healthier atmosphere: All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, protected veteran status, or disability status.
Imprimis Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test before beginning employment. In addition, employees in certain positions are subject to random drug testing.
We offer excellent starting salary plus benefits including a 401k plan.
ImprimisRx is one of the nations leading ophthalmology compounding businesses ImprimisRx is headquartered in San Diego, CA and operates two production and dispensing facilities based in Ledgewood, New Jersey. ImprimisRx s 503B outsourcing facility produces formulations for office use in accordance with current good manufacturing practices (cGMP), the highest federal quality standards for drug manufacturers in the country. Its 503A pharmacy produces customizable, patient-specific formulations pursuant to a physician prescription for several chronic care needs. There have been over one million eyes served by the formulations produced at these facilities.