Job Title: QA Specialist

Location: Frederick, MD

Duration: 06 Months

Description:

Job Title - QA Specialist I

Onsite

Non-shift

Knowledge:

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.