Job description

SUMMARY OF FUNCTIONS
The SSM Compliance Specialist II supports new product and existing product development by working to ensure compliance with cGMPs, company and customer quality standards as well as external regulatory requirements.

MAJOR DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.

• Develop and maintain a strong command of SOPs, cGMPs and associated regulations. Apply this knowledge in the everyday work environment, providing consultation as necessary. Actively participate in resolving quality issues. Make suggestions for quality system improvements and recommend methods to increase the quality of products and/or services. Participate in the implementation of these improvements.
• Develop an understanding of the inventory management system used for raw materials, intermediates and finished goods and assist with maintaining accuracy.
• Develop an understanding of the function and basic operation of SSM equipment and processing techniques to enable effective performance of other duties.
• Coordinate periodic review and revision of SSM SOPs.
• Track and manage timelines for SSM quality events and initiatives. Coordinate efforts to ensure timelines are met and when necessary assist SSM production staff with extension requests.
• Assist with the review and/or approval of master and production batch records
• Assist SSM production staff with writing deviations and investigations. Identify areas of concern and communicate to management.
• Assist SSM production staff with the change control process.
• Assist SSM production staff with the CAPA process.
• Assist SSM production staff with review and approval of equipment qualification documentation, including protocols and reports.
• Assist SSM production staff with training programs for new hires.
• Provide oversight to the GMP inventory system and assist warehouse operations when necessary including the assignment/generation of inventory item numbers and any applicable change control or procurement processes.
• Represent SSM during regulatory, client, and internal audits including tours of SSM production areas.
• Coordinate SSM responses generated from regulatory, client, and internal audits. Engage relevant subject matter experts to assist with responses when necessary.
• Perform all duties safely in accordance with AMRI Safety Program, OSHA requirements, FDA regulations, and all applicable federal, state and local regulations.
• Communicate with development chemists, analytical chemists, QC and QA personnel, material handling personnel, maintenance and engineering personnel, information systems personnel and specific members of management (when requested).
• Recommend and implement methods to increase the quality of products and/or service.
• Participate in self-development activities and training of others.
• Exhibit safety awareness and safe work practices.
• Perform other related duties as may be reasonably assigned in the course of business.

QUALIFICATIONS
**
**To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Education and/or Experience

• Bachelor’s Degree or equivalent in a technical discipline such as science or engineering or experience in a laboratory or chemical manufacturing environment. Will substitute relevant experience in lieu of educational requirements.
• A minimum of three (3) years industrial cGMP experience in an FDA-regulated pharmaceutical environment.

Language/Communication Skills
Ability to read, analyze, and interpret technical procedures and governmental regulations. Strong written communication skills including the ability to independently write complex reports, business correspondence, and procedures. Ability to read and interpret regulatory and technical documents such as FDA and ICH guidance documents, protocols, reports, and standard operating procedures. Strong verbal and presentation skills including the ability to speak effectively before small groups of customers, auditors or employees of the organization.

Mathematical Skills
Ability to apply concepts of basic algebra and geometry.

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.

PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to stand; sit; and use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms and talk or hear. The employee is occasionally required to walk; climb or balance; and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, depth perception, and ability to adjust focus. Incumbent may be required to obtain/qualify for and maintain the clearance to wear a respirator at a “class B” level or above following OSHA mandated guidelines.

WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is frequently exposed to wet and/or humid conditions. The employee is occasionally exposed to moving mechanical parts and risk of electrical shock. The noise level in the work environment is usually moderate.

All interested applicants must apply online. 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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Job Type: Full-time

Pay: $55,000.00 - $68,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person

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