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QA Specialist

EASi

06/22/2021

Posting ID: JP-002186317

Full Time
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Description:

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements.

Participates in developing Standard Operating Procedures to ensure quality objectives are met.

Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs)

Reviews routine manufacturing, environmental monitoring and quality control data for in-process and finished products.

Develops solutions to more complex problems and identifies deviations from accepted practice and evaluates impact assessment as required.

Maintains day-to-day communication with the CMOs to ensure deviations, change controls, batch records, and other GMP/GDP documentation is forward processed and closed out in a timely manner.

Ensure that batch records are reviewed and released in a timely manner to maintain adequate MOH levels.

Participates in the writing of annual product reviews.

May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products.

Works with Research and Development during new product start-ups, and identifies routine checkpoints for new products and processes.

May assist with compliance audits as required.

Interfaces with contract manufacturers to address documentation and compliance issues.

Demonstrates thorough knowledge of FDA/EMEA standards and quality systems, and the interface with other functions like manufacturing, distribution and maintenance.

Review CMO deviations and close out Minor investigations in validated systems. Co-review Major and Critical CMO deviations with QFSL.

Demonstrates audit and investigation skills, and report writing skills.

Demonstrates strong verbal, technical writing and interpersonal skills.

Taken on other tasks as needed.

Skills:

aseptic technique, quality assurance, Quality assurance, Gmp, Fda, Capa, Batch record, QA, Inspection, Sop, batch record review, BRR, aseptic

Additional Skills & Qualifications:

Additional Skills:

Demonstrates proficiency in application of QA principles, concepts, industry practices, and

standards.

Demonstrates thorough knowledge of FDA / EMEA standards and quality systems, and the

interface with other functions like manufacturing, distribution and maintenance.

Demonstrates strong knowledge of six sigma, LEAN and root cause analysis tools used for

identifying and correcting deviations

Demonstrates audit and investigation skills, and report writing skills.

Demonstrates strong verbal, technical writing and interpersonal skills.

Demonstrates proficiency

3+ years of relevant experience in a GMP environment related field and a BS or BA.

Someone who will be detail orientated and push to get things done with CMO's

Go-getter personality

Not someone who will wait for instructions and takes initiative to get things done

Science background is a must

Team does not have the time to train someone from scratch

Needs to have background with BRR

Sterile background- manufacturing or QA

Lyophilized- filling, capping

Fundamentals of environmental monitoring

Process knowledge of making lyophilized products is good.

About EASi:

Amazing begins here. EASi is a leading global services company specializing in engineering and sciences. For more than 35 years, EASi has delivered critical services across a range of industries, including energy and utilities, transportation, heavy equipment, consumer and industrial products, medical devices, pharmaceutical and biotechnology, as well as academic and health care research. By adapting to the constantly evolving needs of our customers, we have built specialized expertise and a multidisciplinary perspective - leveraging cutting-edge technology and processes - to constantly improve and innovate. Through EASi's flexible solutions and consultative approach, customers in engineering and sciences can expect unparalleled quality, increased speed to market and collaborative customer engagement services.

Headquartered in Hanover, Maryland, EASi has 3,700 dedicated employees across North America, Europe and Asia. EASi is an Aerotek company, a leader in the recruiting and staffing industry. Aerotek is an operating company of Allegis Group® Inc., a global leader in talent solutions. To learn more about EASi, visit EASi.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Kristyn Snow

Email: ksnow@aerotek.com

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