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7 days old

Quality Assurance Specialist

Kelly Services
Warren, NJ 07059
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Quality Assurance Specialist** at a prestigious Fortune 500 company working in **Warren, NJ.**


**Important information:** This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.


**Job Title: Quality Assurance Specialist**


**Pay: $34.65 per hour**


**Job description:**


The Specialist is responsible for quality and disposition activities in accordance with policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release and product release, as needed, ensuring accurate and timely maintenance and review of manufacturing batch record documentation, On-Site coverage/participation in QA Shop Floor activities, and performing document issuance for manufacturing.


**Detailed Position Responsibilities**

Participate in QA shop floor program.

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.

Able to effectively multi-task.

Revise department SOPs

Real time review and approval of executed batch records.

Responsible for Material Status Changes of production/drug product materials.


**Qualifications**

Must have advanced knowledge and experience with cGMP manufacturing, Quality, and compliance.

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.

Is recognized Subject Matter Expert within the group.

Provides guidance to other employees in interpretation of complex data.

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.


**Education And Experience**

Bachelors Degree Required, Science related degree preferred.

Minimum of four to five years of related Quality Assurance experience in the pharmaceutical industry required

Equivalent combination of education and experience acceptable.

Strong knowledge of cGMP principles required.

Strong cross-functional collaboration experience required.

Labeling experience is highly preferred.

Excellent Communications Skills are required.


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com **.**


**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**


**Kelly Services is an Equal Opportunity Employer**


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-02-22 Expires: 2021-03-25

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Quality Assurance Specialist

Kelly Services
Warren, NJ 07059

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