СШАPharmaceutical Manufacturing Operator
вчера
30–35 USD / часСШАJuniorOnsite
sterilizationcompoundingrecord keepingautomated filling machines
Responsible for manufacturing sterile medications and operating in controlled environments.
Обязанности
- We are looking for a dependable Pharmaceutical Manufacturing Operator who will manufacture sterile medications. As a manufacturing operator, you will keep accurate records, keep up to date with training, and manufacture medications for Hims & Hers Pharmacy.
- Operate in ISO 5-8 environments performing essential duties to manufacture sterile products.
- Routine compounding operations including preparation and sterilization of labware, measuring, compounding, filing 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 minimum errors and within an appropriate timeline.
- Ability to 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- Restock medication shelves and supply bins; rotate and remove outdated materials and chemicals; maintain a clean working environment.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.
Требования
- 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 such as filter integrity machines, scale, pH meter, analytical balance, autoclave, depyrogenation oven, manual and automated crimper machines, aseptic filling machines, check weighers, sonicator machines, fogging machines, incubator, mixer, air/ nitrogen cylinders, and viable, non-viable air sampler devices. Ability to troubleshoot the machines.
- Experience with sterility via filtration of the products, working with different filter types. Familiar with different types of terminal sterilization.
- Cleaning, operating, changeover, assembling, and disassembling of the machine parts for the bag filling, PFS filling, and buffer bag filling machines.
- Cleaning and operating the formulation and filtration vessels by performing PHT (Pressure Hold Test), Clean In Place (CIP), Sterilization In Place (SIP), and batch processing using an automated system.
- Knowledge of cleaning and maintaining the above-mentioned equipment.
- Knowledge of cleaning and maintenance of 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, against black/ white back grounds, using a timer.
- Experience performing weighing of ingredients and mixing, pulling supplies, and material transfer per protocols and batch record steps.
- Deep Knowledge of cGMP, CFR 21, sterile compounding, and aseptic techniques, preferably related to a 503 B outsourcing manufacturing facility.
- 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 while taking appropriate breaks.
- 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. Previous knowledge of working with quality-related documentation is 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.
Условия
- Competitive salary & comprehensive health benefits including medical, dental & vision
- Conditions of Employment:
- This position will require working with Hazardous Drugs (HD) and would require that Personal Protective Equipment (PPE) be worn for the length of time spent working with these drugs. These items would include gloves, respiratory protection, gown, and other items as required.
- This position requires medical approval to wear respiratory protection in the form of negative or positive pressure respirators, including N95, full face respirator, SCBA, or Powered Air Purifying Respirator (PAPR).
- Physical exertion required. Including, but not limited to, walking up to 50% of the time, standing up to 100% of the time, squatting and bending up to 20% of the time, and lifting up to 80% of the time for up to a twelve-hour shift. Must be able to lift up to 50lbs.
- Due to the risk of reproductive harm in handling or compounding certain Hazardous Drugs (HD), associates must be willing to confirm that they understand the potential risks (teratogenicity, carcinogenicity, and reproductive effects) of handling hazardous drugs.
- We are committed to building a workforce that reflects diverse perspectives and prioritizes ethics, wellness, and a strong sense of belonging. If you're excited about this role, we encourage you to apply—even if you're not sure if your background or experience is a perfect match.
- Hims considers all qualified applicants for employment, including applicants with arrest or conviction records, in accordance with the San Francisco Fair Chance Ordinance, the Los Angeles County Fair Chance Ordinance, the California Fair Chance Act, and any similar state or local fair chance laws.
- It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
- To learn more about how we collect, use, retain, and disclose Personal Information, please visit our Global Candidate Privacy Statement .
Другое
- Hims & Hers is the leading health and wellness platform, on a mission to help the world feel great through the power of better health. We are redefining healthcare by putting the customer first and delivering access to care that is affordable, accessible, and personal, from diagnosis to treatment to delivery. No two people are the same, so we provide access to personalized care designed for results. By normalizing health & wellness challenges and innovating on their solutions, we’re making better health outcomes easier to achieve.
- Hims & Hers is a public company, traded on the NYSE under the ticker symbol “HIMS.” To learn more about the brand and offerings, you can visit and. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit.