Audit Specialist

2 months ago

Bangor, United States Biospectra Inc Full time
Job DescriptionJob DescriptionExciting career opportunity alert Join our team at BioSpectra, where we support the top 25 pharmaceutical companies globally. We are looking for an experienced Audit Specialist to contribute to our success.

Are you passionate about ensuring compliance and maintaining ethical standards? Join us as an Audit Specialist and lead the audit function with precision. We are seeking a candidate with a strong understanding of regulations, risk management, and ethical standards to evaluate approved procedures and practices. Attention to detail, proactivity, and exceptional communication skills are key attributes for this role.

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, Inc. 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 Specialist will be responsible for the completion of the required activities within the Compliance Inspection Program, Internal Audit Program, and Customer Audits Program. Additionally, the Audit Specialist will be responsible for conducting paper-based and virtual supplier and service provider audits as required by management.

Essential Duties and Responsibilities:

  • Ensures that BioSpectra’s facilities are functioning in accordance with established quality policies and procedures through facility walk through and document/record review and approval, Internal Audits, Compliance Inspections, and Communication with personnel.
  • Lead Auditor for Internal Audits of BioSpectra's GMP systems across all BioSpectra facilities.
  • Lead Auditor for Supplier, Manufacturer, and Service Provider Audits for both paper-based and virtual audits as required by management.
  • Coordinates with BioSpectra Departments for any resulting Corrective and Preventative Actions including assessment for Compliance to BioSpectra's Quality Agreements with Customers.
  • Completes Internal Audit Effectiveness Assessments to determine if an internal audit closure has been completed successfully or requires additional root cause analysis and CAPA.
  • Executes the Compliance Inspection Program to ensure facilities and systems are compliant to internal and regulatory standards.
  • Executes the Customer Audit Program to ensure audits and follow up activities are compliant to BioSpectra, customer, and regulatory standards.
  • Reviews current and new Guidance Documents and implements an action plan for BioSpectra to incorporate any changes to the current Quality management System.
  • Supports the enhancement of the Quality Management System across the BioSpectra Organization.
  • Performs quality and GMP based training as necessary.
  • Other duties may be assigned as deemed appropriate by management.

Qualifications:

  • Four-year degree in Science or related field
  • 4 year minimum experience working in a cGMP environment ideally Active Pharmaceutical Ingredient related
  • Has a working knowledge and understanding of ICH Q7, 21 CFR 210 and 211, Part 11 and Annex 11
  • Knowledge of other applicable US FDA regulations and guidance documents related to pharmaceutical ingredient manufacturing
  • Ability to define problems, collect data, establish facts and draw valid conclusions
  • Experience with relevant software applications including MS Office, Excel, Minitab 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.

Work Hours:

  • Exempt Position
  • Minimum of 40-45 Hours Week, or other agreed upon documented schedule
  • Ability and willingness to work from all BioSpectra facilities

Ready to make a difference in the biopharma industry? Apply now and be part of a talented team driving excellence at BioSpectra

#biospectracareers

#LI-BM1

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