Specialist Qa34

Job Description
Biotechnology industry experience
Detailed technical understanding of bio-processing unit operations
Skilled in performance of GMP production operations
Regulatory knowledge and interactions
Participate and help lead cross-functional teams
Ability to communicate and collaborate with technical and management staff within manufacturing, process development, and quality
Organizational, technical writing and presentation skills
Project management skills
Knowledge of control charting
Availability to support non-standard shift
Experience in Root Cause Analysis (Fishbone, 5 Why’s, Kepner Tregoe)

ISHIHARA TEST is required
Qualifications
Master’s degree in Sciences/Engineering and 3 years of directly related experience or
Bachelor’s degree in Sciences/Engineering and 5 years of Manufacturing experience in a GMP regulated industry

Additional Information
Non Standard-Third Shift
Please send resume in Word or PDF format

Job Type: Contract
Experience:
root cause analysis: 4 years (Required)
regulatory knowledge and interactions: 4 years (Required)
biotechnology industry: 4 years (Required)
technical writing and presentation: 4 years (Required)
control charting: 4 years (Required)

Education:
Bachelor's (Required)

Language:
English and Spanish (Required)

Contract Length:
5 - 6 months

Work Location:
One location

This Company Describes Its Culture as:
Outcome-oriented -- results-focused with strong performance culture