QUALITY ASSURANCE SPECIALIST
WARREN, NJ

100 % Onsite Position

Required Skills:

• B.S. degree required, minimum of 1 years of experience in the pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.
• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, 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.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.
• Must have strong authorship.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes.
• Able to effectively multi-task.
• 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, and analytical thinking.
• Is recognized Subject Matter Expert within the group.
• Provides guidance to other employees in interpretation of complex data.

Working Conditions: (US Only)

• Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time.
• Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
• This job description is intended to describe the general nature and level of work being performed by the person assigned to this position.
• The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
• This job description does not state or imply that the above are the only duties and responsibilities assigned to this position.
• There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job.
• Employees holding this position will be required to perform any other job-related duties as requested by management.

Project Description:

• The Specialist is responsible for quality and disposition activities in accordance with the Client's policies, standards, procedures and Global cGMP.
• Functional responsibilities include performing incoming material release and performing document issuance for manufacturing.
• Issue and upload controlled documents.
• Responsible for disposition of incoming production materials.
• Order supplies for the department.
• Routinely recognizes and resolves Quality issues.
• Inform management of proposed solutions.
• Seeks management guidance on complex issues.
• Proposes solutions for complex issues and works with management to resolve them.
• Follows established procedures and performs work as assigned.
• 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.

This 12+ month position starts ASAP.

ALPHA'S REQUIREMENT #23-00305
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

Job Type: Full-time

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Health savings account
• Referral program
• Vision insurance

Schedule:

• Monday to Friday

Work Location: One location

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