Quality Systems Specialist - II
Company: Unicon Pharma
Location: San Mateo
Posted on: November 14, 2021
Location: Foster City, CA 94404
Duration: 06 Months-Contract.
Note: 1 shift Wed-Sat 9a-7p (4day/10hr)
Conducts a comprehensive and critical evaluation of Laboratory
records including but not limited to content, results, data
accuracy and scientific relevance, format and adherence to GMP.
Performs a thorough review of raw data and documentation to ensure
compliance to applicable specifications and protocols.
Supports the laboratory testing group instrument qualification and
method validation review.
Performs procedural and method revisions, where necessary.
Conducts GMP review of laboratory notebooks, logbooks and
associated forms including electronic raw data to ensure compliance
with data integrity policy.
Supports OOS/OOT investigation and CAPA implementation
Conducts off hour (early morning/late night/weekends) data review
to support production needs.
Provides new hire training.
Specific Required Skills:
Advanced knowledge of current Good Manufacturing Practices (GMPs),
pharmacopeia and compendial requirements, and pharmaceutical
Strong knowledge of regulatory requirements surrounding Data
Familiarity of analytic testing methods and validation including
Ability to apply critical thinking and good judgment.
Strong organizational and problem solving skills.
Strong verbal, written, and interpersonal skills are required.
Proficiency in Microsoft Office and laboratory computerized systems
such as Empowerand LIMS.
Keywords: Unicon Pharma, San Mateo , Quality Systems Specialist - II, Other , San Mateo, California
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