Manufacturing Associate I-OSD 1st Shift

Alkermes; Cincinnati (OH); On-site; USD 35,000 - 55,000; Full time

Job summary

An exciting opportunity awaits you in a dynamic and collaborative environment where you'll play a crucial role in the manufacturing of pharmaceutical products. In this entry-level position, you'll work closely with a dedicated team in a GMP setting, ensuring the highest standards of quality and safety. Your responsibilities will include production, bulk packaging, and inspection of drug formulations, along with assisting in facility cleaning and maintenance. This role is perfect for someone eager to learn and grow in the pharmaceutical industry, offering a chance to develop valuable skills and knowledge while contributing to impactful projects that improve patient care. Join a forward-thinking company committed to excellence and innovation in healthcare.

Qualifications

• Entry-level position in a GMP environment with team collaboration.
• Basic knowledge of safety and quality standards is essential.

Responsibilities

• Production and inspection of pharmaceutical drug formulations.
• Assisting with facility cleaning and operational maintenance.

Skills

Basic knowledge of the Scientific Method

Basic math skills

Basic knowledge of GMPs and GDPs

Basic knowledge of chemistry and biology

Basic knowledge of HAZCOM and RCRA

Good documentation skills

Ability to learn to operate production equipment

Detail-oriented

Ability to work well in a team environment

Positive attitude

Education

High School diploma or equivalent

Bachelor's degree in a relevant field

Associate degree in a science/technical discipline

Tools

Microsoft Suite

SAP

Veeva Vault

LMS

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:

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

Preferred Qualifications:

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

Education and Experience:

Manufacturing Associate I

Basic Qualifications:

1. High School diploma or equivalent

Preferred Qualifications:

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

Manufacturing Associate II

Basic Qualifications:

1. High School diploma or equivalent
2. 1-3 years of experience in a pharmaceutical manufacturing operation.

Preferred Qualifications:

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

Manufacturing Associate III

Basic Qualifications:

1. High School diploma or equivalent
2. 4-5 years of experience in a pharmaceutical manufacturing operation.

Preferred Qualifications:

1. 2-3 year experience in OSD Manufacturing
2. Associate degree or higher in a science/technical discipline
3. 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:

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