Manufacturing Associate

Astrix; Wilmington (OH); On-site; USD 28,000 - 30,000; Full time

Job summary

Astrix in Wilmington, OH, is seeking capable operators for sterile pharmaceutical filling lines. Responsibilities include equipment cleaning/assembly/setup, operation, batch processing, and following SOPs with careful documentation in a cGMP environment.

Candidates must be able to gown aseptically, sanitize areas, and maintain training proficiency. Shift options include 1st and 2nd shifts with 4x10 schedules; weekend coverage may be required.

Qualifications

• High School diploma or equivalent required.
• 0-1 year of experience in a sterile pharmaceutical operation preferred.
• Associates degree or higher in science/technical discipline preferred.
• General knowledge of aseptic practices and cGMP.
• Ability to read and follow SOPs/MPRs and documentation requirements.

Responsibilities

• Read and follow SOPs/MPRs/Procedures.
• Document all work as required by cGMP on a timely basis.
• Operate filling equipment for microspheres/suspensions/liquids.
• Perform aseptic gowning and maintain gowning qualification.
• Perform clean room sanitizations.
• Perform equipment prep/assembly/setup.
• Shift coverage and weekend work may be required.
• Assist with development and validation activities as required.

Skills

Aseptic fundamentals

Math skills

GMP knowledge

Safety knowledge (HAZCOM/RCRA)

Mechanical aptitude

Education

High School diploma or equivalent

Associates degree or higher in science/technical discipline

Job description

2 openings available: 1st shift and 2nd shift

• M-Th 3pm-1:30am 4x10 2nd Shift (pay rate: $22/hour)
• M-F 7-330pm 1st Shift (pay rate: $20/hour)

Summary:

Perform all necessary operation activities related to filling of microsphere/suspension/liquid products. These activities include but are not limited to the following: Equipment Cleaning/Assembly/Setup, Equipment Operation, Batch processing. Read and follow detailed written SOP/MPR’s with thorough documentation of operations according to cGMP. Ability to aseptically gown and maintain gowning qualification. Perform Area Sanitizations as needed. Maintain individual training proficiency through individual Learning Management System.

Responsibilities:

• Read and follow detailed written SOP’s/MPR’s/Procedures.
• Document all work as required by cGMP’s on a timely basis.
• Execute tasks as directed with close attention to detail.
• Monitors process with close attention to detail.
• Follows Alkermes internal policies.
• Abide by all safety requirements as defined by the company.
• Perform Aseptic Gowning and maintaining gowning qualification. (this includes wearing of hood, coverall, boots, mask, goggles, gloves)
• Perform clean room sanitizations.
• Perform equipment prep/assembly/setup.
• Operate equipment used in filling of microspheres/suspensions/liquid products.
• Assist with Development and Validation activities as required.
• Other tasks as assigned by Manager.
• Shift coverage and weekend work may be required.

SKILLS/ABILITIES:

• General knowledge of aseptic fundamentals.
• General math skills, including using metric weight system.
• General Knowledge and Adherence to Current Good Manufacturing Practices.
• General Knowledge HAZCOM RCRA, and other safety requirements.
• Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment.

PERSONAL ATTRIBUTES:

• Integrity/Ethics
• Detailed Oriented
• Self-Motivated
• Responds Quickly to Assignments
• Works Well in a Team Environment.
• Adapts Well to Changing job duties.
• Takes Ownership and is Willing to Learn new tasks/skills

Qualifications

Minimum Education & Experience Requirements:

Basic Requirements:

• High School diploma or equivalent.
• Preferred Requirements:
• 0-1 year of experience in a sterile pharmaceutical operation.
• Associates degree or higher in science/technical discipline.