At BioSpectra Inc., we pride ourselves on how we effectively deliver high-purity ingredients for the top 25 pharmaceutical companies in the world. We're proud to set the standard of excellence in our industry. To help us continue growing, we're seeking an Audit Technician to launch their career. The ideal candidate is someone with compassion for their work and a strong desire to succeed and grow both personally and professionally.
BioSpectra, Inc. is a privately held, family-oriented organization and a U.S.-based manufacturer of GMP pharmaceutical-grade ingredients, including API's, excipients, GMP process chemicals, and bulk GMP buffers and solutions. BioSpectra currently has facilities located in Bangor, Wind Gap, Stroudsburg, PA, and Scarborough, Canada.
Why should you join BioSpectra, Inc.?
- Support our current customers who are the top 25 pharmaceutical companies in the world
- Develop your career with a growing organization with ample opportunities for professional and personal development
- Comprehensive Benefits Package (Medical, Dental, Vision, Company paid Life Insurance, Tuition Reimbursement)
- 401K Retirement Savings Plan - Company matches $2 per $1 of employee contribution on the first 4%
- Excellent Paid Time Off Programs include vacation, sick, & personal time, plus paid holidays
Job Summary: The Audit Technician will be responsible for assisting with the completion of compliance inspections, Internal Audits, and Customer Audit related observations as assigned by management. Additionally, the Audit Technician will be responsible for retrieving documentation for virtual and on-site supplier and service provider audits as required by management. Essential Duties and Responsibilities:
- Assists with ensuring that BioSpectra's facilities are functioning in accordance with established quality policies and procedures through Compliance document review and approval, Internal Audits, Compliance Inspections, and Communication with personnel.
- Supports the Lead Auditors in Internal Audits for the following systems: Facilities and Equipment, Materials, Quality, Laboratory Controls, Production, and Packaging and Labeling operations or other records and data to determine the efficiency and effectiveness of systems.
- Supports the Lead Auditors in Supplier, Manufacturer, and Service Provider Audits for both virtual and on-site audits as required by management.
- Supports the coordination and tracking with respective department owners for any resulting Corrective and Preventative Actions including assessment for Compliance to BioSpectra's Quality Agreements with Customers.
- Assists with gathering documentation and evidence for the completion of Internal Audit Effectiveness Assessments to determine if an internal audit closure has been completed successfully or requires additional root cause analysis and CAPA.
- Performs Compliance Inspections as assigned to ensure facilities and systems are compliant to internal and regulatory standards.
- Supports tracking and trending of customer audit observation responses and associated CAPAs to ensure they are completed in the agreed upon time frame.
- Supports customer audits by gathering documentation and performing pre-audit inspections as required by management.
- Reviews assigned current and new Guidance Documents and supports the implementation of an action plan for BioSpectra to incorporate any changes to the current Quality management System.
- Other duties may be assigned as deemed appropriate by management.
Qualifications:
- Two-year degree in Science or related field.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Experience with relevant software applications including MS Office, Excel, and Adobe.
- Ability to communicate effectively with staff, management, customers and/or regulatory agencies.
- Ability to handle sensitive information in a confidential manner.
- Close vision, distance vision, ability to adjust focus, ability to distinguish color change, and the ability to use a computer for extended periods of time.
- Ability and willingness to work from all BioSpectra facilities.
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.
Work Hours:
- Non-Exempt Position; Shift 8am to 4:30pm.
- Minimum of 40-45 Hours Week, or other agreed upon documented schedule.
- Ability and willingness to work from all BioSpectra facilities.