We are a nutritional supplement manufacturing company located in Commerce City, Colorado. We are seeking a Formulation and Manufacturing Technician with a mechanical background and experience in oral solid dose applications. In this position the candidate will manufacture and package tablets and perform routine preventative maintenance on equipment. Produce quality tablets that unequivocally meet the specifications detailed in the Production Master document, following cGMPs and standard operating procedures.
Candidates should have knowledge of manufacturing procedures, good manufacturing systems and familiarity with regulatory and Standard Operating Procedures. Experience in granulation, milling, compression, and encapsulation. Conformance to GMP and SOP requirements by following batch records accurately in granulation, encapsulation, and compression. Perform setup, cleaning and troubleshooting of tablet presses and coaters. Demonstrated ability to read and interpret documents such as operating and maintenance instructions and procedure. Experience in a pharmaceutical or nutraceutical environment.
BASIC FUNCTION: Responsible for performing tasks to specifications related to oral solid and liquid dose pharmaceutical manufacturing. Processes include weighing raw materials, blending, tablet manufacturing, and coating.
The ideal candidate for this position has 5+ years' experience working in a pharmaceutical or nutraceutical manufacturing environment
The Formulation and Manufacturing Technician will be a 1st shift position.
1906 values people with great character, dedication, and commitment, and our company gives such individuals expansive opportunities for growth and development.
Duties & Responsibilities:
Performs all the duties necessary to granulate and compress products which includes the setup and use of manufacturing equipment such as but not limited to tablet presses, coaters, dedusters, metal detectors, disintegration testers, friabilators, mixers, and hardness testers.
Performs all the duties necessary to coat products which includes the setup and use of manufacturing equipment.
Operates tablet presses as a primary function.
Presses tablets in accordance with product specifications.
Samples tablets for QC testing.
Quality and Compliance
Total compliance at all times by following batch records instructions, SOPs and all company policies
Comprehends and adheres to all pertinent Health and Safety Regulations, Policies and Procedures.
Comprehends and adheres to all related SOPs as well as Batch Records and Protocols.
Ensure proper execution of Master Batch Records, standard operating procedures and validation protocols. Clearly and accurately completes all required documentation.
Completes all required Training activities.
Monitor batch production to ensure documentation is correct; product meets batch requirements, BOM is correct; tablets meet target weights, and completes documentation and mathematical calculations without error.
Checks for accuracy of all materials as well as all in-process materials as per current SOP.
Maintains a clean and organized work area. Will properly clean, label and transport all in process and finished product to the designated storage area, will maintain the immediate work area in a clean and safe manner, and perform room and equipment cleanings as needed.
Clean and sanitize manufacturing rooms and equipment including walls, floors, and ceilings per current SOPs
Disposes of defective or outdated products.
Identify and report quality issues
Perform all in-process testing and inspections as required by the Master Batch Record (i.e. tablet thickness, tablet hardness, visual inspection, etc.)
Report to the Supervisor all concerns of possible contamination, equipment damage, hygiene issues, illnesses, batch and BOM issues, and any other concerns that relate to Good Manufacturing Practices. When in doubt asks questions and seeks for assistance from supervisors, managers or other operators.
Equipment / Maintenance
Ensure cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s). Perform equipment inspections and completes all pertinent documentation.
Ensure accurate completion of equipment logs.
Perform equipment inspections and completes all pertinent documentation.
Troubleshoots equipment malfunctions and makes minor repairs.
Perform routine operator preventative maintenance on machines regularly, and report any concerns or damages to the supervisor immediately.
Wear appropriate safety equipment and personal protective equipment. Remaining alert and aware of work operations to avoid accidents and incidents.
Follow established hygienic practices to include wearing of appropriate garments, personal hygiene, hand washing and sanitization prior to work and at any time during working hours.
Work scheduled shifts and overtime as required to meet assigned goals.
Willingness to travel to other manufacturing locations
Ability to stand for extended periods of time (approximately 6-8 hours)
Ability to repeatedly bend, twist, and stoop throughout an 8-10 hour shift
Ability to frequently lift up to 25 kg (55 lbs.)
Ability to be exposed to considerable noise from machinery
Ability to be exposed to nutraceutical raw materials and powders
Ability to wear PPE as required
Experience in food/pharmaceutical/nutraceutical processing operations, FDA regulated industry, or combination of experience, education, and training that provides the level of knowledge, skills, and experience needed to successfully perform the job.
Able to read, write, and speak in English
Excellent written and verbal communication skills
Excellent math skills
Ability to read and comprehend SOP’s, Batch Records and training documents.
Ability to multitask effectively
Excellent interpersonal skills and ability to effectively interact with different functional groups
Mechanically inclined candidates are preferred
Manual Dexterity is required.
Must be able to move about the facility
Must be able to ascend/descend a ladder
High School Diploma or equivalent.
Computer literacy and solid communication skills (in English) are a must.
5+ years working in a pharmaceutical or nutraceutical manufacturing environment.
Solid understanding of cGMP practices and concepts.
Highly competitive hourly salary including bonus. Target range of $20-$25 per hour
100% company paid health insurance
1906 is an equal opportunity affirmative action employer and administers all personnel practices without regard to race, color, religion, sex, age, national origin, disability, sexual orientation, gender identity or expression, marital status, veteran status, genetics or any other category protected under applicable law.
Paid Time Off
Professional Development Assistance
Folks just to say with pride. The 1906 operations took everything into consideration over this learning exercise with the virus. Very tight and focus group put up all the needed defenses to insure all of our safety along with our communities we live.
High school or equivalent (Preferred)