Pharmaceutical Manufacturing Operator

Hims & Hers•Los Alamitos, CA

1d•$30 - $35•Onsite

About The Position

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.

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 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.

Nice To Haves

Previous FDA trainings desirable.
Previous knowledge of working with quality-related documentation is desirable.

Responsibilities

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.