Job Description

Job Title: QA Lead Technical Operations
Location: Devens, MA
Duration: 6 Months+

Pay Range: $60 - $66/hr. on W2

Job Summary:
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.


Roles & 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.

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:

• Prefer associate's degree with 1-3 years GMP experience in the Pharmaceutical or related industry.
• High school diploma required.

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