Job description

QA SHOP FLOOR SPECIALIST – 1ST SHIFT
SUMMIT, NJ

1st shift work schedule: M-F, 9 am-5:30 pm
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 #22-02864
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Type: Contract

Schedule:

• 8 hour shift

COVID-19 considerations:
vaccinated

Ability to commute/relocate:

• Summit, NJ 07901: Reliably commute or planning to relocate before starting work (Required)

Experience:

• Manufacturing: 1 year (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: One location