Quality Specialist

Responsibilities include, but are not limited to:

Quality Systems Oversight

• Support site-level quality systems such as: Change Control and Deviation processes in accordance with internal procedures and regulatory expectations.
• Ensure timely and thorough completion of assigned documentation tasks.
• Support cross-functional teams quality system updates.

Computerized System Compliance

• Support Data Integrity initiatives for electronic systems including TrackWise, EDMS, and other validated platforms.
• Participate in system upgrades, validation activities, and periodic reviews to ensure ongoing compliance.

Documentation & Audit Support

• Collaborate with Document Control and QA teams to ensure controlled documents are accurate, current, and compliant.
• Support internal, client, and regulatory audits by preparing documentation as assigned.
• Assist in batch record review/filing, complaint investigation initiation, and audit readiness activities as needed.

III. Essential Skills, Experience, Qualifications:

Required:

• 2 years of experience in a GMP-regulated environment (pharmaceutical or dietary supplement preferred).
• Experience with 21 CFR 111, 21 CFR 211, or 21 CFR 11.
• Working knowledge of Quality Systems and Quality Assurance
• Experience with Microsoft Office Suite.
• Excellent written and verbal communication skills.
• Strong organizational and time management abilities.

Preferred:

• Experience with TrackWise and/or EDMS or equivalent
• Lean Six Sigma or similar continuous improvement training
• Project Management

Job Types: Contract, Temp-to-hire

Pay: $30.00 - $35.00 per hour

Expected hours: 40 per week

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Application Question(s):

• What is your email address, contact number, and the best time to reach you?

Education:

• Bachelor's (Preferred)

Experience:

• Quality Systems and Quality Assurance: 4 years (Preferred)
• 21 CFR 111, 21 CFR 211, or 21 CFR 11.: 2 years (Preferred)
• GMP regulated environment (pharmaceutical): 3 years (Preferred)

Work Location: In person

Salary : $30 - $35