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Associate Specialist, Quality Product Release

Summit, NJ 07901

Posted: 05/22/2023 Job Number: 23960369

Job Description

ASSOCIATE SPECIALIST, QUALITY PRODUCT RELEASE
SUMMIT, NJ
100% Onsite position.

Project Description:
  • 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.
  • 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.

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

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 6+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Kevin: kevin@alphaconsulting.Com

ALPHA'S REQUIREMENT #23-00991
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE

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Kevin Anderson

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