Responsibilities:

• Excellent employment opportunity for a QA Specialist I in the Frederick, MD area. (onsite)-non-shift
• 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.

Experience:

• 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.
• 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.

Job Type: Contract

Experience level:

• 2 years
• 3 years
• 4 years
• 5 years

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• GMP/GLP: 2 years (Required)
• Quality systems: 2 years (Required)
• FDA regulations: 2 years (Required)
• Deviation/CAPA/CC: 2 years (Required)

Shift availability:

• Day Shift (Required)
• Night Shift (Required)
• Overnight Shift (Required)

Work Location: In person