Manufacturing Technician - Equipment Prep

Full Time Mount Laurel Township, NJ, US Why Stokes? Stokes Healthcare is a privately-owned business comprised of three divisions:Stokes Pharmacy (503A pharmacy),Epicur Pharma (503B facility) and STEP labs. The these divisions operate out of separate facilities in Mount Laurel, NJ, following different regulations and are guided by different principles. Stokes Pharmacy was founded in 1975. The pharmacy formulates custom prescription medicines for both humans and animals. The business has grown from a small, hometown operation in Medford, New Jersey, to a respected pharmacy serving the entire U.S., enabled by sophisticated online ordering and overnight shipping capabilities. In 2016, Stokes Healthcare built a world-class facility (which became Epicur Pharma), as a testament to the commitment to providing the highest level of quality.Adding a unique offering to the veterinary industry, Epicur Pharma is an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets. Epicur follows Current Good Manufacturing Practices (cGMP) which are the same rules and regulations followed by commercial manufacturers. Epicur Pharma is proud to be a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. Epicur products are distributed directly to veterinary hospitals from our manufacturing facility and offered through Stokes Pharmacy for individual patient prescriptions. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. Equipped with advanced instrumentation and operated under strict regulatory standards, STEP Labs provides comprehensive services in microbiological and chemistry analysis with a focus on quality, data integrity, and timely results. Stokes Healthcare has built a reputation for unwavering quality and superb service by holding fast to the founders’ commitment to traditional craftsmanship, combined with today’s most advanced knowledge and technologies. In a field where many corporate-owned pharmacies try to compete on price, Stokes has always put safety and quality first because patients’ lives depend on it. At Stokes, we offer competitive salaries and a comprehensive benefits package that includes medical, dental and vision coverage, life insurance, Health Reimbursement Account, Flexible Spending Account, 401(K) retirement savings plan with a generous employer match, a bonus program, paid holidays, vacation and personal time, and an excellent working environment. We are conveniently located in Mount Laurel, New Jersey, just minutes from Philadelphia and the NJ shore. Job Title FLSA Status Non-exempt Starting at $20/hour based on experience plus twice a year bonuses Summary The Manufacturing Technician-Equipment Prep is responsible the set-up, cleaning and packaging of materials and equipment that will be used for batch production, while following appropriate procedures in a clean and safe work environment meeting all cGMP, FDA, DEA, OSHA and other applicable regulations. This individual will work with other Equipment Prep Manufacturing Technicians under the direct supervision of the Manufacturing Manager. Essential Duties and Responsibilities include the following. Other duties may be assigned. Practice current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDocP) at all times Work on basic to routine assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs) Report to Manufacturing Manager on a regular basis online performance and reports any issues that need to be resolved Prepare equipment and components for sterilization Properly operate processing equipment including autoclaves, ovens, dishwashers, and vial washers and document use in relevant logbook in accordance with GDocP Clean (manually and clean-in-place) and assemble glassware and equipment for production Perform clean-in-place and sterilization-in-place of tanks Coordinate with Supply Chain Technicians to ensure in-stock conditions of all consumables and manufacturing materials Refills supplies when necessary Complete and maintain documentation related to assigned work, including logbooks, batch records, etc. Properly use all equipment in the lab that is necessary for task Report all unusual, non-routine occurrences when performing tasks (NOE report) Ensure training is up-to-date and assist in training other technicians Demonstrate, at all times, safe work habits and maintain a safe work environment Required Education and Experience High school diploma or general education degree (GED) Compounding and/or laboratory experience preferred but not required Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations Receives general instructions on routine work and detailed instructions on new assignments Follows written Standard Operating Procedures (SOPs) and Master Batch Records; must be able to take variant action only with approval of department management Independent action and initiative in resolving issues Demonstrates strong safety orientation, with strict adherence to established safety practices and standards Takes independent action and initiative in resolving issues\ Demonstrates good verbal, written, and interpersonal communication skills Must be able to stand for an 8 to 10-hour period Must exhibit punctuality and low absenteeism Must be able to change into gowns and work attire as required for the task Occasionally lift up to 50 lbs., routinely lifts up to 25 lbs. Communication Skills Detail Oriented Organization Skills Technical Capacity Thoroughness Supervisory Responsibility This position has no supervisory responsibilities. This job operates primarily in a controlled laboratory environment. This position requires the use of standard office equipment, and frequent standing and walking. Physical Demands 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. May need to lift up to 50 pounds on occasion, routinely lifts up to 25 pounds This position is moderately active and requires standing and walking for a majority of the shift Able to sit and/or stand 8-10 hours or more per day as needed Position Type and Expected Hours of Work This is a full-time position. Because of the nature of the business, work schedules may vary at times. Travel No travel is expected for this position. Disclaimer The above job description is intended to describe the general nature and level of work being performed by employees assigned to this job. It is not designed to capture or illustrate a comprehensive list of all responsibilities, duties, and skills required of employees assigned to this job. AAP/EEO Statement Stokes Healthcare is an Equal Employment Opportunity and Affiutive Action Employer. #J-18808-Ljbffr Epicur