Compliance Specialist

Responsibilities

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• The Compliance Specialist reports to the Quality Compliance Manager. A significant amount of time is spent collaborating inter-departmentally to facilitate CAPA initiation, timely execution, and closure.
• The incumbent is also responsible for ensuring documentation, practices, and procedures are in compliance with SOPs and cGMPs.
• The incumbent will be responsible for reporting CAPA metrics on a routine basis to directly leadership as well as site leadership.
• The incumbent will participate in all quality systems as a secondary resource, as required.
• Must be able to communicate knowledgeably about quality and technical issues.
• Sufficient image and impact to influence peers in all areas of the operation. 
• Level of direction required to accomplish routine and atypical tasks is minimal requiring a high degree of autonomy.
• Detail oriented / Have an in-depth understanding of cGMPs / Learn quickly / Demonstrate initiative
• Encourage/assist other departments in following SOPs and cGMPs.
• Responsible for interpreting trends in pending CAPAs so as to allow for proactive response to issues.
• Responsible for accumulating and reporting quality metrics for tracking results .
• Perform SOP and cGMP training (as required) for the group per SOP guidelines.
• Responsible for establishing and re-evaluating personal and departmental goals to ensure optimal levels of efficiency and productivity.
• Responsible for providing monthly report data in a timely manner as required.
• Perform other assigned duties as may be required in meeting company objectives.
• Responsible for establishing strategies and providing the leadership necessary to accomplish department goals while following all SOP/GMP guidelines.
• Responsible for performing follow up on all supplied information in order to perform verification checks on proposed corrective actions.
• Other activities as assigned by the Manager.

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Supervisory Responsibilities

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This job has no supervisory responsibilities.

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Education And/or Experience

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A Bachelor's degree in the Sciences and 2-3 years pharmaceutical experience, or 5-10 years relevant experience is recommended, of which 1-2 years is in a regulated field (pharmaceuticals, .

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Language Skills

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Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write clearly. Ability to speak effectively.

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Mathematical Skills

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Ability to apply basic math concepts.

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Computer Skills

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Proficient in the use of MS Word, Excel, Outlook and Access, as this individual will perform work within these systems on a routine basis.

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Other Skills And Abilities

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• Excellent Communication skills, both verbal and written
• Ability to organize time in order to successfully manage multiple projects and priorities
• Ability to read, understand, interpret and implement technical writing and instructions.
• Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals
• Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style.
• Experience with computers is required
• Good typing skills are required
• Requires the ability to work independently.
• Excellent knowledge of cGMPs and SOPs. 

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Other Qualifications

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Must pass background check

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Must pass drug screen

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All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.