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Description

Compliance Specialist is responsible for implementing policies, procedures and standards at a site to ensure compliance with regulatory and corporate requirements. This includes management of GMP document control systems, development of annual product review reports, administration of the compliant program, supporting site audits and development & delivery of GMP trainings.

Policies, Procedures and Standards (40%)

•Implement and enforce policies, procedures and standards

•Conduct internal site audits, document audit results and ensure site audit preparedness

•Maintain knowledge and understanding of applicable GMP regulations, regulatory agency guidelines, industry association guidelines and good practices

•Manage complaint program and monitoring for trends, coordinate requirements of investigation from site when required

Document Control Systems (30%)

•Site owner and subject matter expert for the management of GMP documentation, change control and CAPA systems

•Manage the document change control processes that involve the receipt, maintenance, approval, distribution, maintenance of files and storage of documents to include, but not limited to: batch records, standard operating procedures, protocols, deviations, investigations and standard forms.

Training/Coaching (30%)

•Develop and implement a standardized training process that complies with all regulatory/corporate requirements (GMP focus) by working with site functional leads, Quality CoE Training & Capabilities Manager, Corporate QA, and training peers to develop processes, tools and templates to deliver a standardized approach

•Establish training curriculum and assignments based on assigned functions in collaboration with site leadership and Quality CoE Training & Capabilities Manager

•Develop and deliver site level GMP training for new employees and re-fresher trainings as required

•Develop, maintain and report appropriate training metrics

Qualifications

4 year degree or equivalent experience

5 years’ experience in a GMP, high paced, manufacturing environment.

Experience in a regulated industry is required; cosmetic and pharmaceutical experience a plus

Experience with improving Quality Systems and process design is required

Experience with authorizing and maintaining procedures and work instructions is required

Knowledge of compliance, related to all applicable Quality Systems Standards national and international, is required

Ability to build and deliver training modules

Creative individual with excellent trouble shooting skills

Strong oral and written communication skills with ability to appropriately communicate information to cross functional stakeholders

Ability to work in a team setting and independently under minimal supervision

Ability to work in fast paced environment supporting the quality assurance/quality control departments

Proficiency in Microsoft Office Suite, Electronic QMS, e-training systems and SAP systems is preferred

Equal Opportunity Employer

It is Company's policy not to discriminate against any employee or applicant for employment on the basis of race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances. The Company will endeavor to provide a reasonable accommodation consistent with the law to otherwise qualified employees and prospective employees with a disability and to employees and prospective employees with needs related to their religious observance or practices. Should you wish to apply for this position or any other position with the Company and you believe you require assistance to complete an application or participate in an interview, please contact [email protected].