We are hiring a reliable QA Specialist I to join our productive team at TekWissen LLC in Frederick, MD.
Growing your career as a Full-Time QA Specialist I is an incredible opportunity to develop productive skills.
If you are strong in cooperation, adaptability and have the right passion for the job, then apply for the position of QA Specialist I at TekWissen LLC today!
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: QA Specialist I
Location: Frederick, MD, 21704
Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or
Good Laboratory Practices (GLPs).
Demonstrates basic knowledge of FDA / EMEA standards and quality systems.
Demonstrates good verbal, written, and interpersonal communication skills.
Demonstrates working knowledge in Microsoft Office applications.
Specific Education & Experience Requirements:
2+ years of relevant experience in a GMP environment related field and a BS.
3+ years of relevant experience and an AA degree.
Prior experience in regulated industry is required.
Pharmaceutical industry experience is beneficial.
Specific Job Responsibilities:
Performs a variety of activities to ensure compliance with applicable regulatory requirements.
Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs) and Good Laboratory Practices (GLPs).
Supports site Quality Systems programs (Deviation, CAPA, CC, etc...)
Works with operating entities with guidance from senior colleagues to ensure that inspections, statistical process control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications.
May support root cause analysis investigations and corrective actions
Provides visibility on key site metrics to site leadership and escalation issues as needed.
Normally receives general instruction on routine work, detailed instructions on new assignments.
TekWissen Group is an equal opportunity employer supporting workforce diversity.
Benefits of working as a QA Specialist I in Frederick, MD:
● Career Growth Potential
● Rapid Progression
● Leading Industry Pay
No CV Required
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