QS Associate - Document Release
- Job Title
- QS Associate - Document Release
- Job ID
- 27739195
- Location
- Mainland, PA,
- Other Location
- Description
-
QS Associate - Document Release, Full-Time
Accupac is hiring for a full-time QS Associate to join our team at our Mainland, PA. facility.
Basic Job Functions:
Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Essential Functions of the Job:- Manage the Annual Drug Product Review (ADPR) process.
- Support the Change Control process including initiation, approvals, and closure.
- Initiate and participate in investigations (including Laboratory Investigations).
- Manage the CAPA process including initiation, closure and performance of Effectiveness Checks.
- Ensure compliance to cGMP standards in the Manufacturing and Packaging areas.
- Perform Production line inspections.
- Issue and perform review of logbooks and notebooks. Perform daily calibration checks of packaging equipment.
- Perform daily checks of temperature monitoring units and notification to management/facilities of excursions.
- Reconcile staged components with approved bill of materials.
- Sample, inspect, and approve customer and vendor components.
- Sample, identify, and submit customer and vendor raw materials to the lab for testing.
- Perform all required testing at established frequency.
- Record all test and inspection results immediately and accurately.
- Compile, organize, and review documentation from customers, Manufacturing, Packaging, and Laboratories.
- Draft, review and approve component MARS, manufacturing batch records, and packaging batch records.
- Review and approve batch records for release of customer product.
- Resolve any documentation discrepancies related to assigned tasks.
- 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
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
-
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
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.
