This position reports to a Supervisor, Manufacturing.

Position Summary:

This entry-level position involves working with a small team in a GMP environment to manufacture commercial and/or clinical-scale batches.

Essential Functions:

The essential functions of this position include:

• Production, bulk packaging, and inspection of pharmaceutical drug formulations
• Assisting with facility cleaning and operational maintenance
• Cleaning all manufacturing equipment and areas
• Assisting with facility and process validations as required
• Assisting with environmental and water system monitoring as required
• Assisting with RCRA and safety inspections as required
• Documenting all work as required by cGMPs and GDPs on a timely basis
• Reading and following all Company SOPs and guidelines
• Abiding by all safety requirements as defined by the company
• Completing other tasks as assigned by supervision

Preferred Qualifications:

• Basic knowledge of the Scientific Method
• Basic math skills including addition, subtraction, multiplication, division, and percentages
• Basic knowledge of and adherence to current GMPs and GDPs
• Basic knowledge of chemistry and biology
• Basic knowledge of HAZCOM, RCRA, and other Safety requirements
• Basic level of mechanical aptitude
• Good documentation skills
• Ability to learn how to operate all types of production equipment (i.e. Blenders, HMIs, Tablet presses, Coaters, Wash off lines, Comils, etc.)
• Ability to read, understand, and accurately follow company SOPs and guidelines
• Basic knowledge of computer systems (Microsoft Suite, SAP, Veeva Vault, LMS)
• Understanding and comprehension of Master Batch Records
• Detail-oriented
• Willingness to learn new tasks and skills
• Ability to work well in a team environment
• Ability to respond quickly and execute assignments
• Willingness to readily adapt to changing job duties
• Positive attitude
• Understanding of and promotion of company and customer objectives
• Ability to follow all procedures to ensure a high-quality product

Education and Experience:

Manufacturing Associate I

Basic Qualifications:

•  High School diploma or equivalent 

Preferred Qualifications: 

• 0-1 years of experience in a pharmaceutical manufacturing operation, preferably in OSD
• A bachelor's degree is preferred; other relevant work experience, education, and training will be considered.

Manufacturing Associate II

Basic Qualifications

• High School diploma or equivalent 
• 1-3 years of experience in a pharmaceutical manufacturing operation.

Preferred Qualifications

• 1+ year experience in OSD Manufacturing
• Associate degree or higher in a science/technical discipline
• Other relative work experience, education, and training will be considered

Manufacturing Associate III

Basic Qualifications

• High School diploma or equivalent 
• 4-5  years of experience in a pharmaceutical manufacturing operation.

Preferred Qualifications

• 2-3 year experience in OSD Manufacturing
• Associate degree or higher in a science/technical discipline
• Other relative work experience, education, and training will be considered

Working Conditions:

Available for any shift with the possibility for overtime (as necessary)

Physical Requirements:

• Ability to push and/or pull equipment or product using a pallet jack
• Ability to lift/move 40 lbs. overhead. 
• Ability to properly gown and don PAPR for potent controlled substance formulations for extended periods of time
• Must be able to be medically cleared for respirator use (PAPR)
• Ability to operate different types of production equipment. 
• Ability to gown correctly for clean room manufacturing operations.  
• Ability to stand or sit for extended periods (up to 4 hours at a time).  
• Must be able to work in an office and a manufacturing environment.