Job description

The Compliance Technician I is responsible for the filing, storage, distribution and organization of regulatory compliance related documents and submissions. The Compliance Technician I is responsible for assisting with the implementation and maintenance of BioSpectra’s Compliance Program.

Major Roles & Responsibilities:

• Obtains, Scans, copies, files, and archives paperwork needed for completion of various Regulatory and Compliance records and maintains indexes as assigned by supervisor/manager
• Ensures Good Documentation Practices are followed on all records prior to scanning, copying, filing, or archiving
• Performs Compliance Inspections as scheduled and acts as an emergency backup for all inspectors
• Trends and reports on Compliance Inspection Key Performance Indicators
• Assists with pre-audit walkthroughs as assigned by Supervisor/Manager for Customer and Regulatory Agency Audits and Inspections
• Assists with the completion of Supplier Corrective Action Request CAPAs through collection of evidence and completion of the CAF form, as requested by supervisor/manager
• Communicates deviations of the processes, documentation and/or records to the Compliance Supervisor and Associate Director, Compliance and provides support for the appropriate corrective and preventative actions in response to the deviations
• Follows up with departments on open Internal Audit CAPAs and reports statuses to the Compliance Supervisor and Associate Director, Compliance by updating the status column in the respective index
• Obtains records requested during audits and provides to the Compliance Supervisor for review prior to submitting to the Associate Director, Compliance
• Assists with gathering the necessary documentation for the completion of Internal Audit Effectiveness Assessments, as assigned by supervisor/manager
• Assists with the completion of Commercial Requests, including but not limited to, Raw Material Statements, Component Statements, BioSpectra Finished product statements, and Product Code Issuance
• Assists with the investigation for non-conformance events by verifying if corrections were made and follows up with open CAPAs, as requested by supervisor/manager
• Maintains organization of BioSpectra’s Quality Agreements with Customers and notifies the Compliance Supervisor and Associate Director, Compliance where procedures may require revision to comply.
• Other duties may be assigned as deemed appropriate by management

Qualifications:

• 2-year science degree or experience that would provide a similar level of knowledge and understanding
• Experience with relevant software applications including MS Office, Excel, and Adobe
• Competent keyboard skills
• Organized, thorough, and detail-oriented
• Strong written and verbal communication skills
• Able to handle sensitive information in a confidential manner

Physical Requirements:

• Standing for extended periods
• Walking for extended periods
• Sitting
• Keyboarding
• Regular lifting of up to 10 lbs.
• Occasional lifting of up to 25 lbs.

Job Type: Full-time

Pay: From $20.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Vision insurance

Schedule:

• 8 hour shift

Ability to commute/relocate:

• Bangor, PA 18013: Reliably commute or planning to relocate before starting work (Required)

Work Location: One location

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