Quality Chemical Laboratories
(QCL), a pharmaceutical testing, manufacturing, and development lab in
Wilmington, is seeking a highly motivated candidate for Quality Manager for our
Sterile fill-finish parenteral manufacturing facility. Requires high-level
quality experience in sterile manufacturing, knowledge of 21CFR parts 210 and
211, knowledge of the FDA Guidance for Sterile Drug Products Produced by
Aseptic Processing – cGMP, and EU GMP Annex 1: Manufacture of Sterile
Medicinal Products. Candidate will be responsible for managing the quality
team, establishing the quality policy for media fills, parenteral
manufacturing, and quality procedures that support parenteral manufacturing.
Duties to include review of qualification and validation documents for all
processes and equipment including protocols and summary reports, risk
assessments, investigations, SOPs to support the quality program, and
establishment of the sterility assurance plan and contamination control
strategy.
QCL offers competitive
salaries commensurate with experience and an excellent benefits package, as
well as great potential for career advancement and leadership in a rapidly
growing company. We now also offer subsidized childcare at our 5-Star
childcare facility.
, or email resumes to [email protected] .
