QA Specialist

Work Schedule:
Mon-Fri (need to be flexible to work on weekends)

Position Summary:

The Specialist is responsible for quality and disposition activities in accordance with Client policies, standards, procedures and Global cGMP. Functional responsibilities include performing incoming material release and product release, ensuring accurate and timely maintenance performing document issuance for manufacturing.

Duties/Responsibilities:

• Responsible for disposition of incoming production materials
• Responsible for release activities for site manufactured drug product.
• Issuance of controlled documents.
• Scans and uploads batch record documents.
• Must have strong authorship and ability to critically review investigations, interpret results and generate technical conclusions consistent with Quality Risk Management.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Knowledge of quality processes, including material disposition, change control, product complains, deviations, investigations, and CAPA management.
• Able to effectively multitask.
• Contributes to process improvements in her/her scope of activity.

Qualifications:

Required Competencies:
Knowledge, Skills, and Abilities

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Directs quality initiatives that accomplish continuous improvement and enhance site quality system efficiencies.
• Must be action-oriented and customer-focused and skilled in decision-making, building relationships, problem solving, conflict management, planning and organizing, coaching others, and analytical thinking.
• Routinely recognizes and resolves Quality issues;
  Informs management of proposed.
• solutions. Seeks management guidance on complex issues. Develops procedures.
• Proposes solutions for complex issues and works with management to resolve.
• Follows established procedures and performs work as assigned.
• Intermediate to advanced ability to interpret results and situations and articulate recommendations for resolution.
• Is Recognized Subject Matter Expert withing the group.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.

Education/ Experience/ License/Certification

• Relevant college or university degree required.
• Minimum 4 years relevant work experience (or equivalent combination of education and experience).

The starting hourly compensation for this assignment is within the range of $/hr. Please note that the final individual compensation and any applicable benefits will be determined by your employer of record (and not the Client). Factors influencing this decision may include the characteristics of the assignment, such as demonstrated experience, required skill, and the geographic location of the job. Compensation details are subject to change.