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QA Specialist

Company: crox
Location: Summit
Posted on: November 26, 2022

Job Description:

*Position*: - QA Specialist

*Location*: - Summit, NJ (Onsite)

*Job Type*: - Long Term Contract opportunity

*REQUIRED COMPETENCIES*: *Knowledge, Skills, and Abilities: *

--- Must have sound knowledge and experience in FDA regulated cGMP Quality Manufacturing operations and processes.

--- Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.

--- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking. --- Must possess an independent mindset.

--- Requires moderate direction to complete more complex tasks; completes routine tasks with little or no supervision.

--- Work is self-directed.

--- Confident in making decisions for non-routine issues.

--- Routinely recognizes and resolves Quality issues; Informs management of proposed solutions. Seeks management guidance on complex issues. --- Develops procedures.

--- Proposes solutions for complex issues and works with management to resolve. Follows established procedures and performs work as assigned.

--- Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.

--- Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, resource allocation, coaching others, and analytical thinking.

--- Understands continuous improvement and improves efficiency and productivity within the group or project.

--- Builds relationships internally within and with cross functional teams. --- Contributes to goals within the work group.

--- Able to recognize conflict and notify management with proposed recommendations for resolution.

--- Able to prepare written communications and communicate problems to management with clarity and accuracy.

--- Able to effectively multi-task.

--- Knowledge of US and global cGMP requirements.

--- Excellent verbal and written communication skills.

*DUTIES AND RESPONSIBILITIES: *

--- Build and maintain relationships with Manufacturing Operations, Quality Control, Manufacturing Science & Technology and other departments to effectively accomplish responsibilities make improvements and resolve issues.

--- Ensure manufacturing compliance with applicable procedures and batch records.

--- Perform real time review of manufacturing batch records. --- Review manufacturing shop floor documentation.

--- Issue production batch records and product labels to Operations.

--- Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality risk management principles.

--- Must be skilled in planning and organizing, decision-making, and building relationships.

--- Knowledge of quality processes, including material disposition, change control, product complaints, deviations, investigations, and CAPA management.

--- Must be able to work in the cleanroom environment for 6-hour time periods.

--- Must be available for weekend and off-shift hours.

--- Must be flexible for shift hour changes to support manufacturing.

*EDUCATION AND EXPERIENCE: *

--- Minimum high school diploma required, with equivalent experience.

Bachelors degree with 4+ years of relevant work experience preferred

--- Aseptic experience preferred, but not required

Job Type: Contract

Salary: $25.00 - $30.00 per hour

Schedule:
* 8 hour shift

Experience:
* Manufacturing: 1 year (Preferred)

Shift availability:
* Day Shift (Preferred)

Work Location: On the road

*Speak with the employer*
+91 8299128841%58047475%

Keywords: crox, New York , QA Specialist, Other , Summit, New York

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