Manufacturing Technician - Non-Sterile (2nd Shift)

Stokes Pharmacy•Mount Laurel Township, NJ

17d•Onsite

About The Position

Stokes Healthcare is a privately-owned business comprised of three divisions: Stokes Pharmacy (503A pharmacy), Epicur Pharma (503B facility) and STEP labs. 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 and formulates custom prescription medicines for both humans and animals, serving the entire U.S. In 2016, Stokes Healthcare built a world-class facility (Epicur Pharma), an FDA Registered 503B Outsourcing Facility, producing drugs such as Tacrolimus Eyedrops, Buprenorphine Injection and Gabapentin tablets, following Current Good Manufacturing Practices (cGMP). Epicur Pharma is a pioneer in animal drug standards, offering the largest selection of manufactured drugs that are traditionally compounded. STEP Labs is a GMP-compliant laboratory that delivers accurate, reliable analytical testing for manufactured pharmaceutical products. 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.

Requirements

Minimum high school diploma or general education degree (GED)
Experience working in manufacturing is preferred
Must develop knowledge of 21 CFR Part 210 and 211 for cGMP operations
Must be capable of working with both small and large machinery
Must be capable of wearing all protective gear (gown, hair bonnet, mask, beard cover, gloves, goggles) and maintain good personal hygiene (makeup, jewelry, and other cosmetics are prohibited from the production areas)
Must possess strong verbal, written, and oral communication skills
Must be able to work independently and with a team
Must possess problem-solving skills
Ability to recognize priorities and actively make productive use of time to build operational efficiencies
Must exhibit punctuality and low absenteeism
Able to sit and/or stand 8-10 hours or more per day as needed
May need to lift up to twenty-five (25) pounds on occasion

Responsibilities

Practice current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDocP) at all times
Responsible for weighing, mixing, manufacturing, and packaging products in accordance with cGMP processes, following SOP’s, and providing accurate documentation in production batch records
Ensure daily operations run efficiently to maintain anticipated production output and maintain product quality for patient safety
Complete batch documentation in accordance with GDocP
Participate in equipment preparation for batch manufacturing, when applicable
Maintain equipment maintenance logbooks for designated equipment
Properly use all equipment (i.e. pH meters, balances, peristaltic pumps, tablet presses etc.) involved in non-sterile manufacturing
Report all unusual, non-routine occurrences when performing tasks (NOE report)
Assist in the development of Standard Operating Procedures (SOP) and other relevant cGMP documentation related to staging processes
Abide by all company gowning requirements as well as operational requirements
Ensure training is up-to-date and assist in training technicians
Attend training classes, workshops, meetings, etc., as required to improve job skills and product related procedures
Work in collaboration with other members of the manufacturing team and other departments such as quality and facility maintenance to achieve company goals
Effectively demonstrate time management during batch processes (e.g. shift change over during batch preparation)
Ability to troubleshoot critical manufacturing processes with appropriate communication and documentation (e.g. batch records, logbooks, and other related documentation)
Perform cleaning and maintenance of environmentally controlled areas
Coordinate with Supply Chain Technicians to ensure in-stock conditions on all manufacturing materials
Demonstrates, at all times, safe work habits and maintains a safe work environment
May participate in other Manufacturing Operations as needed