Qs Associate - Document Release

QS Associate, Full Time
Accupac is hiring a full-time QS Associate to join our 1st shift team at our Mainland Location.
The basic job functions of the QS Associate are to Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Basic Job Functions:
Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Essential Functions of the Job:​​​​​​

• ​​​​Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.
• All production control records have been compiled and are complete and accurate.
• All Laboratory Services release testing showed satisfactory conformance to bulk and finished product specifications.
• Execute or coordinate the resolution to excursions identified during the batch review process.
• Issue and perform review of logbooks and notebooks.
• Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
• Adherence to customer release requirements.
• Update paper and electronic records.
• File and archive documentation.
• Perform other duties as assigned.

Minimum Requirements of the Job:

• Comply with all company policies, SOP’s, current Good Manufacturing Practices and other relevant regulatory requirements.
• Maintain training at or above 90% of assigned curriculum.
• Possess Good Documentation Practices.
• Possess a working knowledge of MS Office applications (word, excel, etc...)
• Attention to detail.
• Ability to work individually and in groups.
• Interpersonal skills.
• Ability to perform basic math skills.
• Ability to read, write and understand English.
• Effective communication skills.
• Meet deadlines as assigned.
• Ability to read, inspect and match batch codes.
• Possess a working knowledge with the use of balances, torque meters, vacuum/seal strength testers, and computer.
• Demonstrate the ability to be flexible to changing requirements and duties of the position.

Physical Requirements:

• Ability to lift up to 40 lbs.
• Walking within the confines of the facility.
• Standing up to 80% of designated shift time.
• Good hearing (ability to hear alarms, ringing).
• Ability to bend/kneel to verify components.
• Ability to see colors and good sense of smell.
• Peripheral Vision.

Supervisory Responsibilities: No
Travel: None
Education and/or Experience: The QA Associate I must have a college degree and 0-2 years of Quality Control/Assurance experience in related field and LIMS experience. The QA Associate II must have a college degree, 2 plus years of Quality Control/Assurance experience in a related field and LIMS experience.