Lot Disposition Specialist

Description

Position Overview:

Performs review activities of finished good products to ensure compliance with applicable SOPs and regulatory requirements are adhered to prior to final release of product.

Responsibilities may include:

• Reviews completed Batch Records for compliance to Regulatory and QuVa SOPs and to ensure product quality and safety standards are met.
• Promptly communicates with Operations and Manufacturing Quality Assurance regarding batch record discrepancies, product issues/variances.
• Escalates procedural deviations or discrepancies that have product impact to the Quality Investigations Team for review.
• Reviews Variances associated with batch records for impact to the product disposition.
• Reviews QC testing results, and EMPM monitoring data, are within specifications.
• Enters QC testing results into Management System to generate product Certificate of Analysis (COA).
• Other duties as designated by Supervision.

Qualifications:

• Legally authorized to work in the job posting country
• Bachelors Degree in Life Science or other related field, preferred
• 2-4 years of experience in Quality Assurance, Sterile Compounding and/or FDA regulated industry, required
• Prior batch record/document review, required
• Strong Microsoft Work and Excel skills

To be considered:

In order to be considered for this position you must complete the entire application process, which includes answering all prescreening questions and providing your eSignature on or before the requisition closing date.

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of QuVa Pharma to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.