Compliance Specialist 1

Job Summary:

Part of Quality and Compliance oversight and function of a GMP sterile fill manufacturing operation. Passion and alignment with our mission, vision, values, and operating principles in order to achieve company initiatives, goals, and objectives.

Job Scope:

The Compliance Specialist is a part of the Quality Unit, which includes Quality Systems (QS) and Laboratory Control (LC). The Compliance Specialist will be a part of the Quality Unit has the oversight of manufacturing and ensures the products manufactured are according to FDA’s regulations and GMP to be pure, safe and effective. The Compliance Specialist will provide support for continuous improvements via system improvements, non-conformance investigations, and implementing Corrective/Preventive actions. The Compliance Specialist should possess proven technical writing and problem-solving skills as well as a desire to develop investigators in the art of problem-solving analysis.

Responsibilities:

• Oversight of the Manufacturing Operations’ and Laboratory Controls’ deviation, OOS, complaint investigation, change management, and ensure non-conformance investigations meet or exceed the internal, customer and regulatory reviewer’s expectations.
• Routinely analyze investigations and CAPA performance to Management team for transparency and drive accountability for non-conformance closure and escalation of adverse trends.
• Tracking and trending of Quality Metrics
• Conduct Risk Assessments for topics such as new product introduction, quality systems evaluations, equipment selection.
• Participate in training on i.e. consequences and outcomes of deviations and investigations.
• Participate in FDA, internal, and customer audits.
• Participate in preparation, documentation, and submissions to regulatory agencies.
• Participate in providing responses to regulatory agencies regarding product information or issues.
• Perform Annual Product reviews
• Other duties as assigned

Job Skills/Knowledge:

• Must have an understanding of FDA regulation and pertinent state and federal laws governing pharmaceutical products, manufacturing, and marketing.
• Desire to own decisions and take responsibility.
• Must have excellent organizational, communication, and coaching skills.
• Ability to gown in an aseptic manufacturing environment.
• Exceptional attendance

Education/Experience

• BA/BS Degree in a science field preferred (i.e., Biology, Microbiology, Chemistry, Pharmacy, etc.) or equivalent combination of education and experience
• Three years prior experience in Quality Assurance in Pharmaceutical Discipline
• Experience in quality management systems
• Experience in quality system audits
• Proficient in Microsoft Office
• Ability to read, write, speak, and understand English sufficiently to perform the duties of this position

Pre-Employment Screening:

• Drug Screening including use of tobacco
• Background Screening
• Visual Acuity Screening

Benefits Summary:

• Paid Vacation
• Holiday, Sick, and Birthday Pay
• Group Insurance Plan including Health, Dental, Vision, Voluntary Life, Short Term Disability, Critical Illness, and Accident Expense
• Flex Savings Plan
• Safe Harbor 401(k) Plan
• Direct Deposit
• Paid Uniforms, including Safety Shoes

Job Type: Full-time

Pay: From $22.93 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible schedule
• Flexible spending account
• Health insurance
• Health savings account
• Paid time off
• Referral program
• Retirement plan
• Vision insurance

Application Question(s):

• Are you a tobacco/nicotine user?

Work Location: In person

Salary : $23