Specialist II, Quality Assurance Floor (3rd Shift, 10pm - 6:30am, M-F) Contract to Hire

Essential Duties

• Identify, communicate and escalate basic technical issues.
• Prioritize own work and works independently on day-to-day activities, additional supervision/guidance for new assignments.
• Point of contact on the manufacturing floor as needed.
• Review executed batch records – real time remediation to prevent deviation (e.g., GDP, settings, alarm response).
• Perform QA activities in the batch record.
• Verify entries occur real time in batch records.
• Perform QC/Retain sampling for each batch.
• General observations regarding procedural compliance of staff.
• Observe the gowning and flow of materials and people.
• Review all operations for the batch were performed accordance with BR.
• Identify, communicate and escalate compliance issues, identify options for resolutions.
• Perform data entry and execute records in electronic systems.
• Responsible for observing all Company, Health, Safety and Environmental guidelines.

Minimum qualifications

• HS/GED with 2-4 years’ experience in a scientific or technical discipline or BA/BS degree in a scientific or technical discipline with 1-3 years related experience.
• Preferably in the pharmaceutical industry.
• The combination equivalent of training and experience.
• Knowledge of GxP Compliance and ISO standards.
• Ability to work autonomously to problem-solve, demonstrating excellent analytical skills.
• Excellent written and verbal communication skills.

Physical Requirements

• Must be willing and able to receive medical clearance to wear a respirator (i.e. Powered Air Purifying Respirator) for entire working shift.
• Must be physically able to gown and de-gown (including the use of a decontamination fogging shower) in up to three layers of clean room and potent compound facility gowning (i.e. Tyvek® jumpsuit).

Pay Range

$27.60 - $41.40 per hour