Quality Systems Associate - Document Release Group
- Job Title
- Quality Systems Associate - Document Release Group
- Job ID
- 27747357
- Location
- Mainland, PA,
- Other Location
- Description
-
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.
- Required Skills
-
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.
