Quality System Technician

BioSpectra, Inc. is a privately held, family-oriented organization. It is an exciting time to join our team as we have recently added a 6th facility to ensure the continued ability to completely and efficiently manage our ongoing growth. This will allow us to support our current customers, who are in the top 25 pharmaceutical companies in the world, as well as our future customers!

BioSpectra offers outstanding career opportunities as well as internal growth focusing on promotion from within. We have dedicated leadership to help assure your success. In addition, we offer educational opportunity with tuition reimbursement options.

Since launching in 1994, BioSpectra began developing and manufacturing the first-ever Quality System Compliant versions of key biological buffers and, we are a cGMP US manufacturer of high purity ingredients for the Bio-Pharmaceutical market.

Join BioSpectra’s highly experienced team and enjoy the stability, personal and professional growth, as well as excellent Health Benefits, Paid Holidays, Life Insurance and an exceptional 401k Plan.

Job Summary:

The Quality System Technician is responsible for the completion of Quality System activities related to Computer System Validation, Corrective and Preventative Action Follow up and Change Control Implementation Follow Up. This position will be responsible for drafting documents related to Computer System Validations in accordance with applicable procedures.

Essential Duties and Responsibilities:

• Communicates CAPA requirements to departments/personnel responsible for CAPA completion and routinely follows up with owners on the status of CAPA completion.
• Tracks CAPA plans and current status along with items required for closure in the applicable index file.
• Provides information regarding the completion of change control activities and ensures each activity is documented to support the closure and filing of change controls.
• Drafts change controls associated with changes to GMP computer systems and assesses requirements for validation where applicable.
• Provides support documents for change controls associated with GMP Computer Systems.
• Collaborates with approved service provider(s), Computer System SMEs, and impacted departments, to ensure compliance with CSV procedures throughout the validation process.
• Completes computer system validation tasks as required throughout the lifecycle of all GMP-related computerized systems.
• Supports the validation of GMP computerized systems through the development, revision, review, and/or execution of validation deliverables.
• Drafts Risk and Gap assessments for GMP computer systems to ensure validation commitments are established and completed in accordance with BioSpectra procedures and industry standards.
• Responsible for drafting test scripts of computer system validation documents for new computer systems or updates to computer systems used by BioSpectra.
• Drafts User Requirement Specifications with impacted departments for new or updated computer systems.
• Provides metrics regarding Quality System Activity.
• Provides requested documentation associated with Quality Systems and GMP Computer System Validation in support of customer audits and regulatory inspections.
• Other duties as assigned.

Physical Requirements:

• 2-Year scientific degree or equivalent experience in a cGMP environment
• Knowledge of cGMP & ICH-Q7
• Experience with Computer System Validation
• Experience with electronic Quality based programs
• Strong technical writing skills
• Strong working knowledge of cGMPs, Part 11, Annex 11 and Data Integrity requirements
• Knowledge of relevant software applications including MS Office and Minitab
• Organized, Thorough, Neat