Pharmaceutical Manufacturing Operator
Hims & HersAbout the role
Hims & Hers Health, Inc. (better known as 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 revolutionizing telehealth for providers and their patients alike. Making personalized solutions accessible is of paramount importance to Hims & Hers and we are focused on continued innovation in this space. Hims & Hers offers nonprescription products and access to highly personalized prescription solutions for a variety of conditions related to mental health, sexual health, hair care, skincare, heart health, and more.
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 hims.com and forhers.com, or visit our investor site. For information on the company’s outstanding benefits, culture, and its talent-first flexible/remote work approach, see below and visit www.hims.com/careers-professionals.
About the Role:
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.
You Will:
- Operate in ISO 5-8 environments performing essential duties to manufacturing 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, visual 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- Restock medication shelves and supply bins; rotate and remove outdated materials and chemicals; maintain a clean working environment.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 reporting 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.
You Have:
- Bachelor’s degree
- A minimum of 2 years 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, auto clave, 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 trouble shoot the machines.
- Experience with sterility via filtration of the products working with different filter types. Familiar with different types of terminal sterilizations.
- Cleaning, operating, change over, assembling, disassembling of the machine parts for the bag filling, PFS filling, and buffer bag for filling machines.
- Cleaning, operating of the formulation and filtration vessels by performing PHT (Pressure Hod Test), Clean In Place (CIP), Sterilization In Place (SIP), and batch processing using automated system.
- Knowledge of cleaning and maintaining above mentioned equipment.
- Knowledge of cleaning and maintenance of the cleanroom and familiar with cleanroom layout, air circulations, pressure differentials.
- Experience working with semi-automated machine and experience 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 cGM
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