Quality Assurance Tech II

Paladin Labs Inc.; New York (NY); On-site; USD 50,000 - 70,000; Full time

Job summary

A leading pharmaceutical company in New York is looking for qualified individuals to ensure compliance and accuracy in batch records. The role involves coordinating with various teams, reviewing quality control checks, and participating in continuous improvement initiatives. Candidates should have experience in a cGMP facility and be attentive to detail. This position offers an opportunity to contribute significantly to the production process and maintain high standards of quality.

Qualifications

• 2-6 years of experience in a quality environment.
• Working knowledge of chemistry required.
• Ability to perform mathematical functions.

Responsibilities

• Review batch records for compliance and accuracy.
• Coordinate with operators and QA for corrections.
• Ensure timely flow of records to the next stage.

Skills

Attention to detail

Teamwork

Communication skills

Problem-solving

Education

High School Diploma

Experience in a cGMP facility

Tools

Trackwise

BPCS

Job description

Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP’s prior to final product release. Coordinates with operators, supervisors, team leaders, and QA to obtain corrections or missing information/sign-offs in the batch folder. Assists in training operators on proper documentation. Reviews quality control checks during and after production. Ensures timely flow of records and product to next stage. Reviews equipment records and logs for completeness and accuracy when required. Maintains various reports for supervisor/manager by inputting/updating pertinent data. Maintains knowledge of cGMPs, most current manufacturing instructions, SOP’s, etc. may prepare revisions as needed. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process. Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change. Assists with issuance of additional labeling (i.e. bottle labels, topserts, folding cartons, etc.) as needed. Issues additional computer generated labeling (i.e. bottle labels, carton labels, etc.) as needed. Understands and performs the task of returning unused labeling to inventory. Understands the inventory and planning systems in BPCS. Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA. Works and communicates effectively in a team environment. Continuous improvement focused and quality oriented as such is expected to participate in related activities and events. Promotes and adheres to safety requirements. Communicates any issues to the oncoming shift. Completes all assigned tasks and documentation according to standard. Performs other duties as assigned by supervision or as required by the position.Maintain various reports for supervisors and or managers. Attend meetings to report out on any release concerns. Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP’s prior to final product release. Follow-up on incidents to ensure resolution to allow folders to release to the next stage. Performs all requirements for final product release. Communicate with other departments to provide information and assist in maintaining efficient flow of paperwork to support production/processing functions. Drives and participates in continuous improvement and quality initiatives. Investigates problems related to complaints. Prepare and perform QA shift turnover.Minimum Requirements**Tech I:** Generally 2-4 years of related experience to perform the essential functions of the position within quality and quantity standards.**Tech II:** Minimum 2-4 years of experience in a cGMP facility and related experience to perform the essential functions of the position within quality and quantity standards**Tech III:** 3-6 years of related experience. Working knowledge of chemistry required with ability to perform simple trouble shooting.* Ability to use Trackwise for exceptions, CAPAs, change controls and DMS.* Ability to log and complete AQL samples.* Perform mathematical functions of medium complexity: add, subtract, multiply and divide all units of measure, including metric.* Ability to identify and address problems involving standardized situations.* Continuous improvement focused and quality oriented as such is expected to participate in and lead related activities and events.* Works and communicates effectively in a team environment.* Understanding of documentation and processes for production/packaging.* Thorough understanding of manufacturing instructions and SOP’s.* Ability to effectively and professionally communicate at all organizational levels in a variety of settings and formats.* Attention to detail and accuracy. **Quality Operations Area – Tech I (In-Process Batch Records Meet Compliance Requirements)*** Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP’s prior to final product release.* Coordinates with operators, supervisors, team leaders, and QA to obtain corrections or missing information/sign-offs in the batch folder.* Assists in training operators on proper documentation.* Reviews quality control checks during and after production.* Ensures timely flow of records and product to next stage.* Reviews equipment records and logs for completeness and accuracy when required.* Maintains various reports for supervisor/manager by inputting/updating pertinent data.* Maintains knowledge of cGMPs, most current manufacturing instructions, SOP’s, etc. may prepare revisions as needed. Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process.* Ensures accurate and up to date tracking of all batch records through the manufacturing and packaging process.* Prioritizes and processes work according to the production schedules; re-prioritizes as schedules change.* Assists with issuance of additional labeling (i.e. bottle labels, topserts, folding cartons, etc.) as needed.* Issues additional computer generated labeling (i.e. bottle labels, carton labels, etc.) as needed.* Understands and performs the task of returning unused labeling to inventory.* Understands the inventory and planning systems in BPCS.* Communicates with production/packaging operators, supervisors, warehouse compliance engineers and QA.* Works and communicates effectively in a team environment.* Continuous improvement focused and quality oriented as such is expected to participate in related activities and events.* Promotes and adheres to safety requirements.* Communicates any issues to the oncoming shift.* Completes all assigned tasks and documentation according to standard.* Performs other duties as assigned by supervision or as required by the position.Maintain various reports for supervisors and or managers. Attend meetings to report out on any release concerns. Reviews batch records for compliance, completeness, accuracy and for any deviations from approved manufacturing/packaging instructions and SOP’s prior to final product release. Follow-up on incidents to ensure resolution to allow folders to release to the next stage. Performs all requirements for final product release. Communicate with other departments to provide information and assist in maintaining efficient flow of paperwork to support production/processing functions. Drives and participates in continuous improvement and quality initiatives. Investigates problems related to complaints. Prepare and perform QA shift turnover.Minimum Requirements**Tech I:** Generally 2-4 years of related experience to perform the essential functions of the position within quality and quantity standards.**Tech II:** Minimum 2-4 years of experience in a cGMP facility and related experience to perform the essential functions of the position within quality and quantity standards**Tech III:** 3-6 years of related experience. Working knowledge of chemistry required with ability to perform simple trouble shooting.* Continuous improvement focused and quality oriented as such is expected to participate in and lead related activities and events.* Works and communicates effectively in a team environment.* Understanding of documentation and processes for production/packaging.* Thorough understanding of manufacturing instructions and SOP’s.* Ability to effectively and professionally communicate at all organizational levels in a variety of settings and formats.* Attention to detail and accuracy.* Ability to use Trackwise for exceptions, CAPAs, change controls and DMS.* Ability to log and complete AQL samples.* Perform