Job Description

Hours will be: 2:00 PM to 1:00 AM
Monday through Thursday morning

Summary

In this role, you will be responsible for performing current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Your primary focus will be managing process documentation in a fast-paced and flexible manufacturing environment!

Essential Functions

Progress towards becoming a Subject Matter Expert on multiple process trains. Review, approve, and update quality documents. Implement Production Batch Records to produce pharmaceutical products. Review implemented Batch Records for compliance before QA review. Assist with schedule adherence by prioritizing daily tasks. Maintain Qualified Trainer status and serve as a designated group trainer. Drive continuous improvement activities and educate peers. Maintain cleanliness of equipment, work areas, and the facility, performing visual equipment inspections. Prepare manufacturing suites and components for the execution of Production Batch Records. Operate in a safe manner, wearing appropriate Personal Protective Equipment (PPE), and promptly identify and report any safety hazards. Follow established waste disposal procedures. Mentor new team members. Serve as a backup for the Team Lead as needed. Support new equipment commissioning and qualification activities. Support audits as the need arises. Follow all relevant Standard Operating Procedures (SOPs), Good Documentation Practices, and Data Integrity procedures. Embody the 4i Values: Integrity, Intensity, Innovation, and Involvement. Fulfill other crucial responsibilities as the need arises.

Education

HS Diploma or equivalent required.

Experience

5 year of work experience in manufacturing/production environment; proven pharma related formulation/production experience.

Equivalency

Equivalent combination of education, training, and meaningful work experience may be considered.

Competencies

To excel in this role, it is essential to have a good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets, and software applications. You should have a consistent track record of producing excellent work with a high degree of accuracy. A strong work ethic, mechanical proficiency, and a genuine desire to learn are important qualities! The ability to multitask and handle shifting priorities in a fast-paced and highly regulated manufacturing environment is crucial. Effective written and interpersonal skills are vital for successful communication. Attention to detail and the ability to follow both written and verbal instructions accurately are key attributes. Proficiency in Microsoft Office Suite, particularly Word and Excel, is expected.

Physical Requirements:

Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing facility. Position requires frequent standing (up to 8 hours) as well as ordinary ambulatory skills and physical coordination sufficient to move about office, laboratory & manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium to heavy weights of 35-50 pounds; arm, hand and finger dexterity, including ability to grasp and move for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate laboratory equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.