Our client is a Biotechnology Pharmaceutical company stablished in this market since more than 40 years ago. They offer to their employee's excellent benefits and opportunities to make career in this dynamic manufacturing company.

We are looking to fill the following position :

• Quality Assurance Specialist - Product Release
• Direct Hire with excellent benefits
• Location: Boca Raton, Fl.
• Salary offered: $65 - $70/K
• 100% on-site position

In addition to competitive compensation, they offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Free shuttle to the Boca Tri-Rail station
• Fast growing company.

Benefit eligible on day 30. 100% paid dental, eye care, life insurance, STD and LTD. 75% employer paid medical with low premiums. PTO of 12 per year for first two years and then goes up from there, holidays, three floating holidays. 4% match 401k vested from day 1. Pet insurance with very low premium.

Just awarded 2023 Best Places to Work!

The QA Specialist - Product Release will have the primary responsibility consisting of the review of controlled documents for accuracy and completeness prior to Quality Assurance (QA) release of product.

Qualifications

• Understand the cGMPs and processes such as Quality Systems (e.g., Deviations, Corrective and Preventive Action reports {CAPAs}, Change Controls, and Out of Specifications {OOSs}).
• Ensure cGMP and regulatory compliance as defined in government regulations such as 21 CFR Parts 11, 210, 211, and 600, as well as compliance with corporate policies and procedures.
• Review and release manufacturing batch records, and any additional supporting documents including but not limited to logs, charts, specifications, and environmental and WFI data.
• Perform usage decisions for batch release in SAP.
• Work with IgG Manufacturing floor personnel and other technical operation departments to resolve documentation and compliance issues.
• Perform period follow-up of ongoing deviations to assure timely closure of documentation and batch release.
• Review and approve Certificates of Analysis for batch release in LIMS.
• Review SOPs and documents from other departments and provide feedback as necessary.
• Perform review and release of products pools when required.
• Initiate Deviations and Change Control as required.
• Review and revise QA SOPs.
• Coordinate and perform any additional activities or projects assigned by QA Management.

Education Requirements:

• Bachelor's Degree required.

Experience Requirements:

• One to two years Quality Assurance (QA) experience in the pharmaceutical, biotechnology, or related industry.
• Experience with LIMS and SAP preferred.

In addition to competitive compensation, they offer a comprehensive benefits package including:

• 401K plan with employer match and immediate vesting
• Medical, Vision, Life and Dental Insurance
• Pet Insurance
• Company paid STD and LTD
• Company Paid Holidays
• 3 Weeks Paid Time Off (within the first year)
• Tuition Assistance (after the first year)
• Easily accessible to Tri-Rail
• Company paid shuttle to the Boca Tri-Rail station