Description
We are seeking a dependable Pharmaceutical Manufacturing Operator to join our team. As a manufacturing operator, you will be responsible for manufacturing sterile medications, keeping accurate records, and staying up-to-date with training.
Responsibilities:
- Operate in ISO 5-8 environments performing essential duties to manufacture sterile products.
- Perform routine compounding operations, including preparation and sterilization of labware, measuring, compounding, filling semi-automatically, and working with automated filling machines.
- Assist and perform compounding, verifying steps, aseptic processing, visually inspecting units for foreign matter, labeling, packaging, and shipping.
- Complete compounding controlled documents and assignments with minimal errors and within an appropriate timeline.
- Perform duties related to material transfer, aseptic processing, and other cleanroom-related duties such as cleaning and maintaining the cleanroom equipment.
- Assist with general maintenance of activities related to the facility and warehouse.
- Communicate with pharmacists and report on issues in the cleanroom.
- Restock medication shelves and supply bins; rotate and remove outdated materials and chemicals; maintain a clean working environment.
- Participate in the inventory as needed.
- Assist in record-keeping according to GDP and report efficiency numbers to the compounding pharmacists.
- Provide quality assurance assistance to compounding pharmacists.
- Knowledge of compounding terminology and calculations.
- Perform other duties as assigned by management or quality assurance.
- Follow GMP, GDP, ALCOA++, FDA, and other regulatory industry-related guidance at all times.
- Experience participating in a manufacturing unit in an FDA-approved GMP facility that includes cGMP compliance and sterile product preparation for pharmaceuticals.
Requirements:
- Bachelor’s degree
- A minimum of 2 years of sterile compounding experience in a manufacturing setting is required.
- Experience with installation, qualification, and operation of common pharmaceutical equipment.
- Experience with sterility via filtration of the products, working with different filter types.
- Knowledge of cleaning and maintaining the cleanroom and familiar with cleanroom layout, air circulation, and pressure differentials.
- Experience working with semi-automated machines and experience with manual 100% visual inspection/ AQL under appropriate light.
- Deep Knowledge of cGMP, CFR 21, sterile compounding, and aseptic techniques.
- Successfully participated in the Aseptic Media Fill process.
- Deep knowledge of line clearance to prevent mix-ups and cross-contamination.
- Perform review of documents for accuracy and completeness at the end of each batch production and follow GDP.
- Experience working in an ISO 5-8 environment and being gowned up for 8-10 hours.
- Comfortable wearing a respirator and necessary PPE.
- Experience working with a team of QA, production, and pharmacists.
- Experience investigating process nonconformance or OSS and running an experimental batch to find answers for investigations.
- Previous FDA trainings desirable.
- Experience with restocking supplies, PPE, and familiarity with what these items are.
- Knowledge of hazardous and biohazardous waste management.
- Knowledge of FIFO and inventory management.
- Self-initiator.
- Great critical thinking and problem-solving skills.
- Ability to work flexible hours, overtime, and weekend shifts.
- Experience with labeling and packaging of the final products and final product counts.
Compensation:
- $30 – $35 per hour
Benefits:
- Competitive salary & comprehensive health benefits including medical, dental & vision