Compliance Specialist

LNK International, Inc. is one of the nation's largest manufacturers of solid and liquid dose, over the counter (OTC) pharmaceuticals. For over 40 years, we have built a reputation for delivering the highest quality products, outstanding service and product innovation.

What sets LNK apart? We believe it is our employees. There is a commitment to quality in every department at LNK. As a member of our Planning Department you will be part of a team of dedicated professionals who support and interact with all areas of the company.

Our full time employees enjoy competitive benefits including:

• 401(k) with generous employer match
• Health Insurance
• Dental Insurance
• Paid holidays
• Paid vacation

The Compliance Speicalist reports to the Manager of Regulatory Compliance and Forecasting, and is a key member of the LNK team.

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• Minimum Education or Experience Required:
  • Position requires a bachelor's degree in science, or related experience.
  • Minimum 3 years' experience in an equivalent role within an FDA regulated pharmaceutical environment preferred.
• Areas of Responsibility:
  • Investigator
  • Liaises with different departments in the organization as a Lead Investigator
  • Proactively assists to identify and facilitate resolution of events to timely completion
  • Proactively manages progression of event investigations and CAPA's to timely closure
  • Determines the risk and measurement in order to monitor the corrective action effectiveness.
  • Preparation of a Quarterly report for management
  • Assist in the Internal Audit process
  • Prepare and perform annual internal audits of multiple departments for compliance.
  • Performs all responsibilities in accordance with company policies, procedures, and all regulatory standards and regulations.
  • Follows all safety procedures, policies, and precautions.
• Required Skills and Abilities:
  • Prior experience in utilizing formal Root Cause Analysis tools for event investigations
  • Demonstrates basic project management skills (organization, collaboration, multi-tasking and communication), attention to detail, and the ability to perform well in a team-based environment are required.

• Excellent verbal & written communications skills, including ability to present information clearly and concisely are required
• Excellent interpersonal and collaboration skills necessary to interface with all levels of the organization are required

• General computer knowledge/skills
• Proficient in Word and Excel.
• Knowledge of Outlook and PowerPoint.
• Knowledge of Trackwise preferred
• Knowledge of Adobe Acrobat preferred

• Physical Requirements:
  • Ability to sit at a workstation for multiple hours.
  • Travel to nearby LNK facilities.
• Work Environment:
  • Fast-paced, office

 

The salary listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job advertisement and may be modified in the future. When determining a team member's base salary and/or rate, several factors may be considered as permitted by law.

 

LNK provides equal employment opportunities to all applicants and prohibits discrimination of any type on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information or any other characteristic protected by applicable federal, state or local laws.