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Manufacturing Technician - Aseptic

hace 27 días

Mount Laurel

Job Description 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 Manufacturing Technician - Aseptic FLSA Status Non-exempt Salary Starting at $20/hour based on experience plus twice a year bonuses Summary This position requires an individual who can work within a cGMP environment in collaboration with other Manufacturing Technicians and under the direct supervision of the Aseptic Manufacturing Supervisor. The successful candidate must be focused on achieving individual and team productivity goals while maintaining a high level of precision and quality. 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, • Responsible for weighing and mixing 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, etc.) involved in compounding and aseptic processing operations, • Assist in the development of Standard Operating Procedures (SOP) and other relevant cGMP documentation related to staging processes, • Report all unusual, non-routine occurrences when performing tasks (NOE report), • 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, • Abide by all company gowning requirements as well as organizational requirements, • 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 Required Education and Experience • 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 small and large pieces of 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 be able to perform aseptic gowning and related procedures, • 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 Competencies • Communication, • Organizational Skills, • Problem Solving/Analysis, • Results Driven, • Technical Capacity, • Detail Oriented Supervisory Responsibility This position has no supervisory responsibilities. Work Environment 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. • Able to sit and/or stand 8-10 hours or more per day as needed, • May need to lift up to 25 pounds on occasion 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 Affirmative Action Employer.

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