Formulation Technician I - 12hr. Rotation Schedule (2/2/3)

Work Schedule

Other

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Cold Room/Freezers -22degreesF/-6degrees C, Laboratory Setting, No contact lens allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions, Warehouse, Will work with hazardous/toxic materials, Working at heights

Job Description

Summary:

Under supervision, monitors all operations of designated chemical process to ensure safe chemical procedures, quality standards and compliance with regulatory requirements for working with and handling raw materials, production intermediates, and final products. Makes decisions that involve direct application of technical knowledge.

Essential Functions:

Operate automated and manual chemical process equipment and conduct associated activities such as sampling, chemical/material handling, cleaning and maintenance in accordance with Standard Operating Procedures, current Good Manufacturing Procedures and Safety guidelines. Maintain a clean and safe process area. Perform manual and computer operations (PLC) to manufacture chemical intermediates and finished products ensuring compliance with all applicable regulatory agencies, as well as company policies and procedures. Monitor all operations of designated chemical process to ensure safe chemical procedures, quality standards and compliance with regulatory requirements. Adhere to Safety & Environmental guidelines/policies as well as cGMP and other applicable regulatory agencies. Accurately record and analyze against standards all processing data gathered from instruments to ensure operating standards are met. Make approved adjustments as appropriate to maintain process parameters within designated limits. Make recommendations regarding improving process operations. Obtain samples of process streams or products in accordance with company procedures; submit samples to QC Lab or perform tests to determine specific properties; Record/analyze results and take appropriate action. Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required. Receive and check raw materials and chemical intermediate deliveries and complete appropriate records in accordance with company procedures (BOP’s/LOM’s/SOP’s). Administer, document and maintain the Quality Systems conformance to regulatory requirements and company policies where appropriate through effective utilization of Quality Systems tools, as well as direct actions. Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains the necessary compliance status required by company and facility standards. Assist with 1st draft of DR’s and the corrective action. Responsible for disposing of any hazardous waste generated in accordance with the company’s Hazardous Waste Training but not limited to:

• DHEC and EPA Hazardous Waste requirements
• Hazardous Waste Satellite Area definitions and requirements
• Hazardous Waste container requirements
• Emergency Response Plan

Responsible for transporting full Hazardous Waste Drum(s) from the Pilot Plant Hazardous Waste Satellite area to the less than 90-day Hazardous Waste Storage Area in accordance with the company’s Hazardous Waste Training. Must be able to work rotating 12-hour shifts with 7 day per week availability and work approved overtime as needed.

Shift: 12hr. Rotation (Days & Nights)

• This is on a 2/2/3 Rotation Schedule

Pay: $21.50/hr. + Night Differential as applicable

Education:

High School diploma or equivalent education required

Preferred Experience:

• Experience working in production/manufacturing as an operator or equipment maintenance technician with manufacturing equipment.
• Experience in a chemical processing or pharmaceutical environment preferred.
• Strong mechanical aptitude preferred.
• To maintain continued employment, must successfully complete Phase I of the Process Tech On -The Job Training program within the first year of employment. This will involve learning/applying chemical technology, math, chemistry, process equipment and control systems. Experience working with Standard Operating Procedures (SOPs).

Competencies: Good knowledge and understanding of basic equipment. Good problem-solving skills and logical approach to solving problems. Demonstrable interpersonal and communication skills to foster the team environment. Ability to read and interpret technical procedures and governmental regulations. Ability to apply basic mathematical principles.

Strong attention to detail and drives to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment. This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays. Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.

Physical Requirements:

Employee is regularly required to stand; use hands to finger, handle, or feel; reach with hands and arms; sit and to talk or hear. The employee is required to walk and stoop, or kneel, crouch approximately 80% of the time. The employee is required to ascend/ descend stairs approximately 20% of the time, lift a maximum of 50 lbs., and sit for a maximum of 4 hours. Specific vision abilities required by this job include close vision and ability to adjust focus

Disclaimer:

This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.

Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees