Formulation Technician I
hace 1 mes
Denver
Job Description Position Summary The Formulation Technician is a hands-on member of the Operations Team responsible for supporting dispensing, formulation, documentation, cleaning, restocking, and production support activities within a 503B pharmaceutical manufacturing facility. This role primarily works in a classified ISO-8 environment and requires employees to follow detailed procedures, wear appropriate PPE, complete documentation accurately and contemporaneously, and maintain a strong focus on cGMP, GDP, safety, quality, and patient safety expectations. This position is a good fit for someone who has prior sterile compounding, pharmaceutical manufacturing, or regulated production experience and is comfortable performing detail-heavy, procedure-driven work in a controlled environment. What This Role Does Day-to-Day In this role, the Formulation Technician may support ISO-8 dispensing and formulation operations, material preparation, equipment setup, batch record execution, documentation, cleaning, and other production support tasks. Daily work may include weighing or measuring materials, preparing components for formulation, following batch records step by step, using equipment according to training, and escalating any process, documentation, equipment, or safety concerns before proceeding. The role requires strong attention to detail, comfort with PPE and gowning requirements, basic arithmetic and chemistry-related calculations, clear communication, and the ability to work carefully in a fast-paced environment with changing priorities. Candidates should understand that even small errors in documentation, calculations, materials, or procedure execution can impact product quality and patient safety. Key Responsibilities • Perform ISO-8 dispensing and formulation operations according to batch records, SOPs, work instructions, protocols, and applicable cGMP requirements., • Prepare, verify, handle, and stage materials, components, product containers, and equipment needed for formulation activities., • Weigh, measure, dispense, or support formulation-related tasks using approved procedures, training, and required documentation., • Use relevant manufacturing equipment, tools, and technology according to established procedures and qualification requirements., • Accurately and contemporaneously document all actions performed in accordance with GDP standards, ensuring entries are complete, legible, clear, and attributable., • Recognize and appropriately respond to potential deviations, calculation concerns, documentation errors, equipment issues, material discrepancies, or process questions; obtain clarification from leadership before proceeding., • Follow all cGMP, health, safety, PPE, gowning, OSHA, EPA, RCRA, DEA, FDA, and company policy requirements., • Safely handle chemicals, corrosives, solvents, pharmaceutical compounds, and other materials according to approved procedures., • Assist with classified and non-classified area cleaning, sanitization, restocking, and maintenance as required., • Support visual inspection, labeling, packaging, and other production activities as assigned based on business need., • Complete required training and qualifications within expected timelines and maintain qualification for assigned job tasks., • Maintain a quality-focused, right-first-time mindset and understand the direct impact of the role on product quality and patient safety., • Communicate effectively across shifts and with Production, Quality, leadership, and other departments as needed., • Make recommendations for process improvements and speak up about viable options for safer, more compliant, or more efficient processes., • Perform other duties as assigned based on business and production needs. What Success Looks Like • Arrives on time and is prepared to work in a classified environment for the majority of the shift., • Follows written procedures exactly and asks for clarification before proceeding when unsure., • Maintains focus and accuracy during detail-heavy dispensing, formulation, cleaning, and documentation tasks., • Completes documentation accurately, contemporaneously, and in alignment with GDP/cGMP expectations., • Understands that patient safety and product quality depend on attention to detail, procedural discipline, and escalation., • Speaks up when something does not look right and stops work when there may be a safety or quality risk., • Works effectively with a diverse team and communicates clearly across shifts or departments., • Demonstrates accountability, professionalism, leadership potential, and a desire to expand knowledge and grow with the company Required Qualifications • High school diploma or equivalent required., • Prior sterile compounding, pharmaceutical manufacturing, or closely related regulated manufacturing experience preferred., • Prior experience operating manufacturing equipment, machinery, or controlled production equipment preferred., • Knowledge of FDA guidelines, cGMP, and GDP preferred., • Knowledge of basic arithmetic and chemistry calculations required; ability to complete or learn weight, volume, unit, and formulation-related calculations., • Must pass required drug screening and any other required pre-employment screening., • Must have excellent attention to detail and strong written and verbal communication skills., • Must be comfortable following detailed procedures and completing documentation accurately., • Must be able to work in a fast-paced environment with changing priorities and production demands., • Must be a team player with accountability, professionalism, and a desire to expand knowledge and grow with the company., • Willingness to participate in training and obtain additional qualifications or certifications as needed., • Leadership ability or demonstrated ability to positively influence peers preferred. Physical Requirements • Ability to work in a classified ISO-8 environment while wearing required PPE for most of the shift., • Ability to stand, sit, walk, bend, reach, and perform repetitive tasks for extended periods., • Ability to lift up to 50 pounds at times and push or pull pallets, product containers, materials, or equipment as needed., • Ability to safely handle chemicals, solvents, corrosives, and pharmaceutical compounds according to approved procedures., • Ability to work in a multiple-shift operation where variable shifts, including weekends, may be required. Work Environment This position primarily works in a classified ISO-8 pharmaceutical manufacturing environment. Employees must follow gowning, PPE, safety, cleanliness, documentation, and conduct expectations at all times. The role may involve working around chemicals, corrosives, solvents, pharmaceutical compounds, manufacturing equipment, and production materials, all of which must be handled according to approved procedures and safety requirements. Benefits: We offer a comprehensive and competitive benefits package designed to support the health, well-being, and financial security of our employees and their families. At STAQ Pharma, all full time employees have access to: • Medical, dental, and vision insurance options, • Employer-paid life insurance and disability coverage, • Employee Assistance Program, • 401(k) retirement plan with employer match, • Paid time off (PTO), sick leave, • 7 paid holidays, • Opportunities for professional growth in a regulated pharmaceutical manufacturing environment, • Employee-focused culture emphasizing safety, quality, and teamwork The application window for this position is anticipated to be open at least 25 days Working hours are Tuesday - Friday, 3:00pm to 1:30am.
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