QS Associate - Batch Record Author
- Job Title
- QS Associate - Batch Record Author
- Job ID
- 27731567
- Location
- Mainland, PA
- Other Location
- Description
-
QS Associate - Batch Record Author, Full-Time
Accupac is hiring for a full-time QS Associate - Batch Record Author to join our team at our Mainland, PA. location.
Basic Job Functions:
Ensure company-wide adherence to cGMP standards, Standard Operating Procedures, and customer specifications.
Essential Functions of the Job:- Prepare, issue, scan, and file quality documents.
- Manage the document life-cycle including, but not limited to, issuing templates, reviewing and revising documentation, and routing documents for approval and qualification.
- Ensure quality documents accurately reflect current procedure.
- Translation of customer specifications into Accupac documentation.
- Manage multiple priorities either independently or part of a team in order to meet key deadlines and communicate issues and progress across all levels of organization.
- Accurately communicate (both written and verbal) progress and updates across multiple levels of the organization and regulatory agencies.
- 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
-
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.