This open application pool is a continuous, open-ended advertisement for those candidates interested in applying to one of the job titles listed below. Open positions may not be available at the specific time of your submission; however, once a position becomes available, candidates with documents in the pool will be screened preferentially. Additional information about the applicant pool and how to apply are listed at the end of this document. The jobs covered in this pool include:
LS0056 – Quality Assurance Supervisor/Manager
Job description of the QA Supervisor/Manager position:
This position requires strong knowledge of process and analytical development, clinical pharmaceutical and biologic manufacturing, and knowledge of non-GxP and GxP quality requirements for pharmaceuticals and biologics. Under the direction of the Director, the QA Supervisor/Manager is responsible for:
• Senior level QA activities to support the ongoing quality system and cGMP campaign activities.
• Directing other staff on the review and auditing of documentation for compliance to good documentation practices and to the technical requirements of directive documents (SOPs, protocols, directive documents, etc.).
• Relying on extensive experience and judgment to plan and accomplish goals; as well as leads deviation, CAPA, and OOS investigations.
• The quality review of testing, quality control, development study documents and other reports/data-forms for accuracy, completeness and compliance to requirements to ensure that QA standards and regulatory requirements are met.
• Change control procedures and events.
• Reviewing QA standards, studying existing policies and procedures, and interacting with personnel and clients to evaluate effectiveness of QA program.
• Assists in writing QA policies and procedures for the organization.
• Coordinating internal and external audits and assisting departments with the coordination of audit information, and recommends appropriate improvement/mitigations.
• Keeping the Director informed of the status of the quality system and unusual occurrences.
Candidates must show attention to detail, have excellent communication skills and be able to work within a team under challenging and sometimes stressful conditions. Candidates should have an exceptional knowledge of commonly-used QA concepts, practices, and procedures within cGMP field. The QA Supervisor/Manager is responsible for improving the organization’s knowledge base of current QA regulations and for informing the Director of any new and/or revised regulations. Candidates must have above average communication skills (writing and speaking) and be responsible for supporting a healthy working environment between other departments where QA is concerned. May oversee personnel engaged in QA support activities. Perform other assigned duties as necessary.
Requires a bachelor's degree and >4 years of full-time experience in the field.
The job title categories within this pool are for positions (when available) that are within a range of 0.5-1.0 Full Time Equivalent (FTE) effort (i.e., 50-100% work effort). Hiring into a particular position at a specific FTE effort is based on the availability of task-specific funds and one’s skill set. Please note that this FTE effort and your salary will be very clearly communicated to you prior to hiring. Continued employment is not guaranteed and is also based on the availability of task-specific funds, one’s skill set and other variables.
Application Deadline: 1-15-2014. NOTE: This pool will expire in approximately one year (1-15-2015) and individuals will need to reapply to be considered beyond that date.