Job Description:
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:
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.
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.
PDN-9d7dd6dc-0c9c-4b6e-a441-f33b1d1b3f9f
