Associate Specialist, Quality Product Release-Disposition

Job Description: 100% onsite
Work Schedule- 11 am to 7:30 pm- Mon-Fri
Position Title: Associate Specialist, Quality Product Release-Disposition
Location: Summit West, S-12
PURPOSE AND SCOPE OF POSITION:
The Associate Specialist is responsible for activities in accordance with corporate policies, standards, procedures, and Global cGMP in support of the QA Disposition group. Functional responsibilities include but are not limited to, ensuring accurate and timely maintenance and review of quality records and manufacturing documentation, inventory management for quality records and manufacturing documentation. Additionally, Associate Specialist supports the receipt of executed batch records and the scanning and uploading of documents and may also support document redaction and document printing.
REQUIRED COMPETENCIES: Knowledge, Skills, and Abilities:

• Must have knowledge and experience with cGMP manufacturing, Quality, and compliance.
• Must possess an independent mindset.
• Work is self-directed.
• Confident in making decisions for non-routine issues.
• Proposes solutions for issues and works with management to resolve. Follows established procedures and performs work as assigned.
• Understands continuous improvement and improves efficiency and productivity within the group or project.
• Builds relationships internally within and with cross functional teams.
• Able to prepare written communications and communicate problems to Supervisors with clarity and accuracy.
• Able to effectively multi-task.
• Knowledge of US and global cGMP requirements.
• Excellent verbal and written communication skills.

Education and Experience:

• B.S degree with 1-3 years GMP experience in the Pharmaceutical or related industry.
• Equivalent combination of education and experience acceptable.

DUTIES AND RESPONSIBILITIES:

• Supports the receiving of executed batch records .
• Supports the scanning and uploading of quality records.
• Must be skilled in planning and organizing, decision-making, and building relationships.
• Contributes to the goals within the work group.
• Teamwork and ability to work effectively across functional groups and teams to ensure requirements are met.
• Able to effectively multi-task.

WORKING CONDITIONS (US Only):
Work is performed in a typical office environment, with standard office equipment available and used. Work is generally performed seated but may require standing and walking for up to 10% of the time. Lighting and temperature are adequate and there are no abnormal conditions caused by noise, dust, etc.
This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.
Additional Job Requirements:
None