QA Auditor I/II/Senior

Onsite training is provided in the QA Auditor's job duties, which include: Perform in-house line audits of pharmaceutical filling and packaging operations; review manufacturing activities and documentation for compliance with SOPs; perform line clearances, in-process, and end-item inspections; review and apply specifications for acceptance of in-coming packaging components, raw materials, and finished products; generate, review, and issue batch production records; release materials & components for use in production; organize and issue printed materials to production; monitor & interpret charts and gauges; log book review, issuance, and archival. Successful candidates will be highly motivated, self-starters with knowledge of contemporary cGMP practices and procedures. Good written and oral communication is essential. Technical writing is a plus.

EDUCATION & EXPERIENCE: Associates degree in Science, or equivalent is required. Bachelors degree in Science, or equivalent is preferred. 1-4 years' experience in or Quality Assurance or Manufacturing, preferably in an FDA regulated environment. Working knowledge of cGMPs is preferred.

Compensation: Starting at $21/hr. Compensation is commensurate with experience.

Typical 1st shift schedule is 4, 10-hour days. Must be available for various days of the week and a 5-day schedule as indicated. Overtime rates apply to hours over 40 per week. Standard work hours for 1st shift are 6:00 AM - 4:30 PM. Alternative work hours/work schedule may be required at the discretion of management.

Knowledge, Skills & Abilities of QA Auditor I/II/Senior include:

• Knowledge and skill in using micrometers, calipers, and light inspection unit is required. Must be able to effectively manage time and work with minimal supervision is preferred, training will be provided onsite.
• Knowledge of Good Documentation Practices.
• Ability to thoroughly review large executed production batch records and identify errors that need correction.
• Ability to pay close attention to detail and coordinate various activities simultaneously.
• Ability to communicate with coworkers, management team members, and other individuals in a courteous and professional manner.
• Ability to work with minimal supervision.
• Ability to maintain confidentiality.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Required qualifications:

• Legally authorized to work in the United States
• 18 years or older