Quality Assurance Specialist I

Overview :

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is with one of our Biotech clients who researches develop and commercializes drugs.

The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi.

Position : Quality Assurance Specialist I

Location : Frederick, MD, 21704

Duration : 6 Months

Job Type : Contract

Work Type : Onsite

Shift : Sunday Wednesday 7am- 5 : 30 pm

Job Description

We are seeking a highly motivated individual to join us as a Quality Assurance Specialist.

In this role you will support the activities of the Quality Assurance department at Frederick, MD manufacturing site.

The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and client quality objectives.

Responsibilities (included but not limited to) :

Provide QA support on the floor for production

Ensure process control measures are in place and followed in product manufacturing

Receipt and disposition of incoming apheresis material.

Oversee and authorize shipment of final product

Verify and ensure timely issuance of production documents and labels

Review batch-related documentation and ensure resolution of issues to release and ship product.

Gather and report metrics to measure performance

Identify continuous improvement actions

Ensure timely resolution and escalation of issues

Ensure all product-related Deviations are initiated, investigated and resolved.

Ensure that associated CAPAs are initiated and resolved, as needed.

Perform lot closure activities.

Ensure approval and timely delivery of final product.

Ensure products are manufactured in compliance with regulatory and GMP guidelines.

Provide Quality Assurance support resolving material, in-process product, final product, environmental, facility and equipment manufacturing issues.

Perform other duties as assigned

Basic Qualifications :

BA / BS in a technical discipline and experience in Quality Assurance or GMP environment (Drug Substance or Drug Product) OR

Associates in a technical discipline (Chemistry / Microbiology / Engineering or similar) and 2+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product) OR

High School diploma and 5+ years of Quality Assurance experience in a GMP environment (Drug Substance or Drug Product).

Preferred Qualifications :

BS / BA + 2 yrs. experience in a GMP related field within a biotechnology, biologics, or pharmaceutical manufacturing facility.

Working knowledge and ability to apply GMPs in conformance to U.S., EU, and ROW standards

Ability to effectively negotiate and build collaboration amongst individuals

Strong teamwork and collaborative skills

Experience with manufacturing investigations, deviations, and CAPA.

General knowledge of aseptic manufacturing processes.

Proficient in MS Word, Excel, Power Point and other applications.

Strong interpersonal, verbal and written communication skills

Comfortable in a fast-paced environment and able to adjust workload based upon changing priorities

Willingness to think outside of the box and adapt best practices to a small, but growing environment

Must be able to work on multiple assignments in collaborative and dynamic environment and demonstrate organizational, prioritization, and time management proficiencies

Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of initial job description.

TekWissen Group is an equal opportunity employer supporting workforce diversity.