Compliance Specialist Ii

Job Description

Job Title:          Compliance Specialist II

Department:   Compliance and Quality Systems

Reports To:     Director, Compliance and Quality Systems

Summary:

The Compliance and Quality Systems Department is responsible for maintaining a positive relationship with Curia customers by completing annual product reviews, responding to necessary field actions, including recalls, and assuring compliance with established Quality Agreements.  This department is also responsible for hosting customer audits, regulatory inspections, and performing internal and supplier audits.  In addition, the department is responsible for tracking and assessing current regulatory trends and citations to determine the impact on Curia's business and recommending strategies for maintaining compliance to senior management.  This department is also responsible for the Change Control system as well as monitoring, trending, and participating in the CAPA management program.

The Compliance Specialist II serves as a compliance resource for the company and provides compliance support with regulatory matters, customer filing strategies, manages the routine renewal of regulatory licenses as well as regulatory updates to the applicable regulatory authorities.  The Compliance Specialist II also supports the negotiation and/or update to customer-specific Quality Agreements.

Essential Duties and Responsibilities:

• Supports Operations and Quality by rendering advice/opinions on compliance with regulatory matters. 
• Provides regulatory assessments of proposed changes, to the facilities or processes, and evaluates the compliance aspects of new products introduced to the facility. 
• Facilitates updates to the facility Quality Risk Management Plan (QRMP) and participates with team members to develop product-specific QRMPs as part of new product introduction.
• Supports customer filings for marketing authorizations by generating portions of the CMC sections of Abbreviated New Drug Applications (ANDA)/New Drug Applications (NDA), and also generates supplements to marketing authorizations as required. 
• Generates routine documentation such as declarations, statements, and certifications regarding the site's compliance with cGMPs, use of latex, BSE/TSE, OVI, BPA, etc., for domestic and foreign agencies. 
• Generates position papers or formal communications that may serve as customer notifications, to address facility modifications/shutdown activities, and new product introductions.
• Generates and amends the facility's Type V master files (e.g., Drug Master File, Biologics Master File, and Veterinary Master File) with U.S. FDA and the Site Master/Reference File for foreign agencies. 
• Files documentation for the state, local, national licenses, permits, establishment registrations, etc., for renewal to maintain the facility's compliance with applicable laws and regulations.
•  Establishes quality agreements with customers, including negotiation of terms/responsibilities and manages revisions to existing quality agreements. 
• Also, monitors compliance with the terms of the customer-specific quality agreement as it relates to regulatory matters. 
• Provides compliance/regulatory approval for new/revised printed components.  
• Supports the site during the state, government, and foreign inspections.  
• Other duties as assigned by the Manager.

Supervisory Responsibilities:                                                        

Not Applicable

Education and/or Experience:                                                       

A Bachelor's degree in the Sciences and five (5) + years in quality assurance and/or compliance/regulatory experience within the pharmaceutical industry OR seven (7) + years relevant experience, of which three (3) + years is in the pharmaceutical industry. 

Language Skills:  

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations.  Ability to write reports, business correspondence, and procedure manuals.  Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

Mathematical Skills:                                                           

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.   

Reasoning Ability:                                                 

Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.                                

Computer Skills:                                                     

To perform this job successfully, an individual should know Database software; Manufacturing software; Spreadsheet software, and Word Processing software. Proficient in the use of MS Word, Excel, Outlook, and Access

Other Skills and Abilities:

• Proficient in problem-solving techniques and demonstrates the ability to troubleshoot with limited supervision. Technical resource for routine issues about compliance with regulatory requirements as needed. Review reports and documents proficiently for completeness and accuracy. Ability to organize time for multiple tasks and respond to high-priority tasks when necessary. 
• Delivers assigned tasks on time. Independently read pharmaceutical publications to be apprised of industry trends.  Attend industry led-training courses, as appropriate.
• A reasonable degree of initiative thinking to resolve problems is required.  The work is routine to moderately complex but covered by well-defined policies, procedures, and regulatory guidance. This position will require the ability to resolve problems, requiring some independent judgment. 
• Actions to be taken will be discussed with the supervisor before resolving non-routine problems. Knowledge of technical writing and technical terminology including technical writing skills.  Ability to assess and communicate regulatory risks.
• Knowledge of aseptic processing and regulatory and industry guidelines and requirements.  Ability to train and counsel Quality professionals and production personnel. Knowledge of cGMPs, GDPs, as well as, sound quality and regulatory principles consistent with 'best practices.' 
• Leadership qualities required.  Attention to detail required.  Ability to read, understand, interpret and apply technical writing and instructions.  Good verbal and written communication skills.  

Other Qualifications:

Must pass a background check

Must pass a drug screen                                                            

Physical Demands:

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit and use hands to handle or feel. The employee is occasionally required to stand, walk, reach with hands and arms; climb or balance and stoop, kneel, crouch, or crawl. The employee must regularly lift and /or move up to 10 pounds, frequently lift and/or move up to 25 pounds and occasionally lift and/or move up to 50 pounds.  Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and depth perception.

Work Environment:

While performing the duties of this Job, the employee is occasionally exposed to moving mechanical parts; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock; explosives; risk of radiation, and vibration. The noise level in the work environment is usually moderate.

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. 

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