QC Analyst I/II (Biotech Manufacturing)

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Who We Are:

We are one of the largest healthcare manufacturing organizations in the world.

We are seeking  QC Analysts (l and II) to join the team in Portsmouth, NH. 

 

Overview/Role Purpose:

 

The QC Analyst will act as a team member of the Quality Control department to support production of in-process and final product drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands.

 

A QC Analyst: Applies job skills and company's policies and procedures to complete a variety of tasks. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. 

 

Key Accountabilities and Duties:

 

• Running test samples for In-Process, Lot Release and Stability studies
• Reviewing assays
• Training others
• Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
• Perform other duties as assigned

Minimum Required Qualifications/Skills:

• AA, BS, or MS - Preferred area of study in Microbiology, Biochemistry or Related Science field
• Use of Microsoft Suites (Word, Excel, Powerpoint)
• Use of Laboratory computer systems
• Strong communication skills, including public speaking
• Ability to interpret data

Qualifications for level II consideration:

• 2-4+ years industry experience, preferably in a cGMP environment
• Previous use of GMP Quality Systems such as: TrackWise, LIMS

Job Expectations:

• Perform assigned, complex and/or varied tasks with guidance from Supervisor
• Prioritization and problem solving
• Comprehend and follow instructions
• Direct, control and plan tasks/projects
• Brainstorming
• Able to communicate in both written and verbal format
• Exercises judgment within defined procedures and practices to determine appropriate action
• Self-motivated team player
• Completes assignments on-time and accurately
• Displays commitment to quality and performs job functions to the best of his/her ability
• Relate to others in a team setting
• Maintain positive attitude in a team environment
• Timeliness in completing assigned tasks
• Works entire assigned shift, including arriving on time