QA Shop Floor Specialist in Summit, NJ at Integrated Resources, Inc

Date Posted: 9/22/2022

Job Snapshot

Job Description

Job Description: Job Description:
The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with Client policies, standards, procedures, and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures, providing real time review of manufacturing records and logbooks, and working with Manufacturing Operations to resolve issues.


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


WORKING CONDITIONS (US Only): Work is performed in a combination of manufacturing cleanroom and office environments, with standard office equipment available and used. Work is generally performed gowned in a cleanroom environment, generally seated but may require standing and walking for up to 50% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
Additional Job Requirements:
None