QA Shop Floor Specialist - 1st Shift

Company: Alpha Consulting
Location: Summit
Posted on: November 26, 2022

Job Description:

*QA SHOP FLOOR SPECIALIST - 1ST SHIFT **SUMMIT, NJ**1st shift work schedule: M-F, 9am-5:30pm **Onsite position **Project Description: ** The QA Shop Floor Specialist is responsible for quality activities supporting Manufacturing Operations in accordance with the Client's 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.* 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 a 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.*Required Skills: ** Minimum high school diploma required, with equivalent experience.* Bachelor's degree with 4+ years of relevant work experience preferred.* Aseptic experience preferred, but not required.* 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 them.* 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.* 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 clean-room 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.This 6+ month position starts ASAP.ALPHA'S REQUIREMENT #22-02864MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEEJob Types: Full-time, ContractBenefits:* 401(k)* Dental insurance* Health insurance* Health savings account* Referral program* Vision insuranceSchedule:* Monday to Friday* Weekend availabilityWork Location: One location

Keywords: Alpha Consulting, New York , QA Shop Floor Specialist - 1st Shift, Other , Summit, New York