Quality Compliance Specialist III

PRIMARY PURPOSE:

Quality Compliance Specialist III apply the knowledge and skills to Formulated Solutions quality system and the principal techniques and procedures employed to assure product quality, quality systems, and regulatory compliances.

MAJOR DUTIES AND RESPONSIBILITIES:

• Ensure that FDA, FDOH regulations are followed and all products are properly registered.

• Accurately organize and maintain files for documents, records, specifications, certificates, labels, change controls, and other documents/data.

• Ensure that QMS systems are in place and promote continues improvements of quality systems

• Lead and/or facilitate gap assessment process and risk management

• Assist with managing documents/procedures related to various departments and revise as needed to ensure processes are defined clearly

• Keep all documents organized and accessible.

• Compile and/or review various key quality indicator trends/metric data

• Promote customer satisfaction

• Provide guidance and coaching for areas of responsibility to less experienced individuals within the organization

• Effectively communicate internally and externally as tasks require

• Follow all safety and GMP procedures.

• Perform other duties as assigned.

QUALIFICATION:

(List the qualification necessary to be successful in the position)

• Required (i.e. knowledge, prior experience)

• Experience following detailed procedures and maintaining accurate records.

• Knowledge of quality assurance/control methods, principles, and practices.

• Knowledge of the relationship of quality assurance to other activities such as Production, Engineering and R&D.

• Skill in interpreting and applying product specifications, technical data, regulations, policy statements and other guideline materials.

• Skill in conducting studies and investigations, problem analysis and developing logical and documented recommendations.

• Skill in written and oral communications and in establishing effective interpersonal relationships.

• Preferred Additional

• Experience working in quality assurance, quality compliances and document control.

• Experience in a regulated industry (e.g. Food and Drug Administration)

CRITICAL SKILLS AND ABILITIES:

(List the skills and abilities necessary to carry out the requirements of the position)

• Ability to maintain detailed and accurate records.

• Ability to use a personal computer and peripheral equipment to accurately enter and analyze data and produce reports.

• Strong math and analytical skills.

• Must be able to recognize own limits and level of competence and ask for direction or help when needed.

• Communicate with others clearly and concisely.

• Ability to work in a fast-paced environment-sometimes with rapidly shifting priorities. Ability to concentrate in such an environment and perform error-free work.

EDUCATION AND/OR TRAINING:

• Working knowledge of GMP and FDA regulations for drugs and/or medical devices.

• High School diploma or equivalent.

• Prior experience in quality control/quality assurance

1st Shift, 8 am - 5 pm