Qa Associate (Pharmaceuticals - 3Rd Shift)

• Hours: 3rd shift (likely 11p-7:30a) M-F
• Starts out on a 12 month contract

Job Description:

Perform all necessary operations activities manufacturing. These activities include, but are not limited to the following: Equipment Cleaning, Equipment Set-up, Equipment/Automation Operation, Batch Processing, and Aseptic Manufacturing. Read and follows detailed written SOPs / Procedures, and detailed documentation of operations according to cGMP. Performs sample collection, equipment/process monitoring, and minor maintenance. Maintain individual training proficiency through individual Learning Management System. Other responsibilities include SOP writing, and review of cGMP documentation

Key Responsibilities:

• Read and follow detailed written SOPs / Procedures
• Document all work as required by cGMPs on a timely basis.
• Executes tasks as directed with close attention to deail
• Monitors Process and with close attention to detail
• Abide by all safety requirements as defined by the company.
• Can work independently without constant supervision
• Follows Alkermes internal policies
• Works well in a team environment
• Perform facility / equipment cleaning and set-up.
• Assist with Development activities and Validation as required.
• Perform aseptic operations.
• Other tasks as assigned by Manager.
• Shift coverage and weekend work may be required

Minimum Education & Experience Requirements:

2 year degree in a science/technical discipline (4 year degree preferred) and / or 3 years relevant manufacturing experience.

Knowledge/Skills Needed:

• General math skills, including simple algebra.
• General knowledge of and adherence to Current Good Manufacturing Practices.
• General knowledge of HAZCOM, RCRA, and other Safety requirements.
• Good level of mechanical aptitude; ability to perform minor non-routine equipment adjustments and diagnose improperly operating equipment
• General computer word processing/spreadsheet skills.
• Good written communication
• Excellent documentation skills.
• Ability to lift / move 40lbs. overhead. Ability to team lift 100 lbs.
• Ability to operate all types of production equipment (i.e. Rockwell HMI, CIP system, etc.).
• Ability to gown in an aseptic manner for clean room operations.
• Ability to read, understand and accurately follow company SOPs and guidelines.