The Quality Assurance Associate is expected to oversee and coordinate all activities related to document control, document change requests and training PiSA BioPharm’s Quality System according to guidance provided by the Director of Quality Assurance and Regulatory Affairs.
Quality Document control via Electronic Quality System.
Write, review and release procedures as directed by Management.
Coordinate training activities for both new and revised procedures.
Participates as a key team member in the QA/RA department on work assignments suited to the department needs.
Other duties as indicated by QA personnel and/or Management.
Basic working knowledge of ISO13485, and 21 CFR 820, 210.?
Experience with document control systems, manage Technical Files is a plus.
Working knowledge of Electronic Quality Systems a plus.
Ability to use statistical software for basic data entry/analysis.
Strong working knowledge of Microsoft Office.
Critical Thinking - Using logic and reasoning to identify the strengths and weaknesses of alternative solutions, conclusions or approaches to problems.
Complex Problem Solving - Identifying complex problems and reviewing related information to develop and evaluate options and implement solutions.
Science/Engineering - Using scientific and engineering rules and methods to solve problems.
Deductive Reasoning – The ability to apply general rules to specific problems to produce answers that make sense.
Active Listening –Giving full attention to what other people are saying, taking time to understand the points being made, asking questions as appropriate, and not interrupting at inappropriate times.
Inductive Reasoning – The ability to combine pieces of information to form general rules or conclusions (includes finding a relationship among seemingly unrelated events.
Minimum B.S. in engineering, biology, biochemistry, regulatory affairs, or related discipline – strong experience may substitute education.
Myst be Fluent in English.
Employee must abide by our company values; Humility, Honesty, Mutual Respect and Equitable Treatment of All,Dependability and Accountability, and
Additional Salary Information: Temporary Position - will discuss with potential candidate.
About Pisa BioPharm, Inc
Medical device and pharmaceutical manufacturer
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