Quality Associate Objective:

The primary responsibility of this position is to provide Quality and Safety support to Production ensuring compliance with all applicable regulatory mandates and customer specific requirements for homeopathic products. Responsible for the proactive participation in the efforts to prevent, detect, report, correct or cause to be corrected the production of non-conforming material or product through routine conduct of audits/inspections at all stages of production. Enforces and educates employees on Good Manufacturing Practices, Good Documentation Practices, and Safety & Housekeeping Policies.

Responsibilities/Tasks:

• Assist in managing all elements of the Quality System in accordance with 21 CFR 210/211.

• Responsible for maintaining various Quality data collection binders, logs and databases.

• Data entry a assigned.

• Review Daily Batch Records and other quality production records for GDP.

• Assist with initiation and follow through of non-Conformances, Deviations, CAPAs, and Change Control.

• Conduct various Quality audits and follow-up with corrective actions and maintain cGMP

compliant documentation of such activities.

• Assist with Incoming Raw Material, Intermediates and Final product sample collection and test coordination.

• Write policies, procedures and forms as needed.

• Maintain Q&S communication boards.

Education Required:

High school required. Four (4) years of college, or equivalent work experience preferred.

Experience Required;

Experience in Medical Device or Pharmaceutical manufacturing environment preferred. High Proficiency with Microsoft Office Suite, especially Excel and MS Word, and Access.

Trainings to Acquire Upon Hire:

Employee will undergo cGMP training and will be trained on all job-specific tasks upon hire by QA manager and those authorized by manager to perform trainings. Each employee will undergo a two-week training period wherein employee will be verified on every task before sent to perform said task un-supervised. A 90-day probationary period of additional observation will follow, after which, an evaluation will be performed to ensure employee has reached goals and expectations set above.

Job Type: Full-time

Pay: $15.00 - $16.00 per hour

Benefits:

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

Schedule:

• 8 hour shift
• Monday to Friday

Work Location: In person