AQA Specialist

The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate's/applicant's qualifications, skills, and level of experience as well as the geographical location of the position.

The end client is unable to sponsor or transfer visas for this position; all parties authorized to work in the US without sponsorship are encouraged to apply.

Our client is seeking an AQA Specialist in Mahwah, NJ.

Role Description

The Analytical Quality Assurance (AQA) Specialist will work with the Quality Control team to work side by side on the floor acting as an in-process quality assurance expert for microbiology and chemistry laboratory activities to include all CGMP activities and testing of any materials, intermediate/finished product, and any utility/facility testing.
Working in a team environment, the AQA Specialist will provide oversite to ensure that all testing is performed in accordance with applicable procedures and compliance standards, ensure Data Integrity is maintained at all times, provide coaching and problem resolution from a Quality Assurance perspective, and act as primary reviewer of QC data for batch disposition.
The AQA Specialist must be well organized and detail oriented, ensure quality events are raised in a timely manner as required.

Skills & Requirements

• Ensure QC processes are controlled and monitored and identify and troubleshoot any quality issues

• Monitor sample custody, in-process product samples, raw materials, and environmental monitoring (EM) samples, if applicable

• Support in the development of methods transfer and validation, troubleshooting, cross validation, IQ/OQ protocols

• Document activities with internal reporting

• Identify training needs and take action to ensure company-wide compliance

• Responsible for the compilation and interpretation of QC Analytical data including OOS

• Responsible to ensure that established testing control procedures and good documentation practices are followed

• Ensure compliance to data integrity and cGMP in QC lab in line with standards prescribed by USFDA

• Ensure that the QC Laboratory is in a ready state of compliance for internal and external audits

• Review of equipment and instrument qualification, calibration, and preventive maintenance, as assigned

• Ensure all monitoring of equipment, utilities and facility is being performed in a CGMP manner, in accordance with site SOP

• Review completion of Tech Transfer of Finished products

• Prepare QC Data Review metrics as applicable

Benefits/Other Compensation

• Disability and Life Insurance

• Employee Assistance Program

• Healthcare Benefits

• Incentive and Recognition Programs

• Paid Vacation and Holidays

• Retirement Benefits

• Sick Pay and Medical Leave

• Health and Fitness Program

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends.
Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers.
You will also get support on resume writing, interview tips, and career planning, so when there's a position you really want, you're fully prepared to get it.

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Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences.
We believe that the more inclusive we are, the better we serve our candidates, clients, and employees.
We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law.
One of Hays' guiding principles is 'do the right thing'.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles.
If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company.
Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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