ABBOTT LABORATORIES Compliance Specialist - Virginia Plant (1st Shift) Salary in the United States

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 103,000 colleagues serve people in more than 160 countries.

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan with a generous company match, and Cash profit sharing, all with a company providing the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

QA Compliance is responsible for maintaining and strengthening the Quality management system so that Abbott Laboratories Altavista meets the standard. The Compliance team manages the documentation system, systems for food safety and laboratory quality, internal and external audit programs, pest control and sanitation program and stakeholders for governmental law and legislation. The Compliance Specialist develops and keeps all Quality management systems in line with relevant laws & regulations through audit reporting and corrective actions, validation and verifications and sanitation program administration. The compliance coordinator focuses on development of quality systems including coordination and implementation of new and existing processes.

Main Responsibilities:

• Review of the Altavista documentation Change Requests and Periodic Reviews for Compliance
• Direct the internal audit system including GMP audits and AQ system elements, any subsequent audits as assigned by Compliance Manager. Manage follow up on corrective actions, findings and metrics reporting.
• Incorporates action plans from the Self inspection, TZO/5S and GMP audits for the overall site health plan and follow up metrics reporting monthly.  This includes escalation items which need follow up after due dates are not met within defined timelines.
• Develop ownership of the POP work stream program and roll out to the site.   
• Monitoring developments in relevant laws & regulations (GMP/HACCP) and standards for new applications in Quality management systems at Abbott Laboratories Altavista.
• Internal Audit metric reporting.
• GMP and TZO, self inspection program reporting and development of site health score card.
• Implement and maintain Quality management systems of Abbott Laboratories Altavista.
• Develop and maintain the following systems: pest control, internal audit program, food safety program, master sanitation or GMP and POP workstreams with integration into quality systems
• Perform internal audits as Lead Auditor and guides external audits of various Governments, bodies and internal supervisors from an audit readiness standpoint.  Including the interfacing with the auditing bodies.
• Responsible for site updates on new regulations for all applicable countries, identity preserved status (Halal, Kosher) and implement through procedure review and updates.
• Coordinate with training team to roll out to employees on updates to polices practices and procedures.
• Make monthly reports for MBR and QMR.
• Short and brief reports for audit debriefs.
• POP work streams – manage program assignments for plant rollout of POP team; participate in community of practice to achieve metrics driven results to meet site goals.
• Environmental Data reporting.
• Sanitation Program development on key areas.
• Drive improvements through sitewide program via training, OJT and documentation to encompass currently outlined gaps.
• Research improvements in cleaning practices and tools.
• Communicate results of EMP data.
• Drive program to meet goals of sanitation metrics.
• Lead meetings with the leadership teams to drive improvement in areas of GMP, Sanitation and PoP
• Fill in as back up to Sanitation or Compliance Manager
• Flexible work schedule as off shift work will be required at various times.

Qualifications:

•  Bachelor’s degree required (Food technology or Chemistry preferred)
• At least 2-4 years in a similar position or 3-5 years in food manufacturing/pharma.

Skills/Background:

• Good understanding and working experience of Quality Systems (HACCP, SQF, GMP).
• Good understanding and working experience of food regulatory guidelines (OU, GMP, HACCP).
• Solid knowledge of law & legislation concerning Food Quality.
• Working experience in a production company (food / pharma).
• Experience with Sanitation, Cleaning, CIP.

* Level of position could be a 12 based on experience

** Shift primarily 1st with off shift requirements