Senior Quality Systems & Validations Specialist

Atlanta, GA, United States

EOE Statement

We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, age, disability, marital status, citizenship, national origin, genetic information, protected veteran status or any other characteristic protected by federal, state, or local law.

About the Organization

Mikart is a contract development and manufacturing organization (CDMO) supplying a comprehensive suite of services across the drug development and commercialization continuum. Wherever you are in the journey from conceptualization to maximizing market adoption, Mikart is your seasoned industry partner - we've been delivering the highest quality products surpassing the most exacting client standards for over 45 years.

Category

Quality Systems

Description

Job Purpose

The Senior Quality Systems and Validations Specialist for Mikart, LLC has the responsibilities for coordinating select quality systems programs and assuring process / cleaning validation activities are performed in compliance with Mikart procedures and GMP regulations. The Senior Quality Systems and Validations Specialist is responsible for targeted duties within the Quality Systems team.

Accountabilities

For responding to and resolving failures in Quality processes, escalating nonconformances, deviations or OOS results for investigation.

For interfacing with Mikart employees in relation to internal or external Quality Systems matters.

For providing back-up Quality Systems support to other Team Leaders, as appropriate.

For preparing written protocols and sampling plans for process validation activities.

For compiling final reports for process validations, which include graphical and statistical analyses of the raw data, discussion, interpretation of results and study conclusions.

For assessing the process validation program on an ongoing basis and maintaining a program that meets the current regulatory expectations and GMP criteria.

For maintaining the cleaning risk assessment and assessing the impact new product introductions have on the cleaning validation programs.

For the generation of cleaning verification or validation protocols and the generation of final reports.

Essential Job Functions

Escalate all quality issues associated with the Quality Systems to the VP, Quality/Regulatory, as appropriate.

Apply theory, technical principles, judgement, and cross-functional expertise to aid in addressing a broad range of company projects.

Contribute to the development and implementation of Standard Operating Procedures and Work Instructions.

Prepare, review and/or approve various types of reports, protocols, and other documents required to support the operations of the company.

Work with internal stakeholders to facilitate successful Quality Systems.

Write process validation protocols, sampling plans for all product process validation studies or activities (may include preclinical and clinical manufacturing, as needed). Work closely with external customers and internally as part of cross-functional teams to assure acceptance, approval, and execution of these activities.

Write final process validation summary reports in a timely manner to support project timelines. The reports include graphical and statistical analyses of the raw data, discussion, interpretation of results and study conclusions.

Work with internal stakeholders as part of cross-functional teams (manufacturing, packaging, marketing, project management, QC and QA) to facilitate successful completion of process and cleaning validation activities.

Write reports, protocols and other documents related to the cleaning validation programs. Assure annual cleaning verification samples are gathered and complete annual summary report.

Assure that appropriate validation-related data is gathered for routine presentation to senior management through the Quality Management Reviews.

Keep abreast of current industry requirements and best practices related to process and cleaning validation activities.

Develop, own, and manage the of Standard Operating Procedures that relate to validation.

Escalate all quality issues associated with failure to meet validation requirements to VP, Quality/Regulatory.

Position Requirements

Key Characteristics

Ability to work by influencing peers and gain their cooperation in dealing with multiple priorities in the management of validation activities.

Solid analytical and problem solving, and decision-making skills coupled with the ability to work both independently and in a team environment.

The ability to compile complex data into simple tabular or graphical format to all conclusions to be drawn.

Strong communication skills and client-facing interpersonal skills. Rational persuasion particularly in the discussions with customers.

The ability to prioritize and manage through complex processes/projects.

High initiative, strong attention to detail and concern for standards are essential.

Drive for continuous improvement of all validation activities to aid compliance and company performance.

Education and Qualifications

B.S. in a scientific/technical discipline with > 4 years' experience within in the pharmaceutical industry.

Minimum of 2 years' experience with process and cleaning validation, including designing, authoring, executing, and coordinating protocols.

Knowledgeable of FDA regulatory requirements applicable to oral dosage pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.

Mastery of the English language and excellent communication oral and written skills are required.

Experience with computer systems, particularly Microsoft Office, and basic typing skills are required.

Physical Demands

Ability to function in a rapidly changing environment and balance multiple priorities simultaneously.

Walking, sitting, standing for long periods, and repetitive hand motions.

This role will be based in Atlanta.

Salary

Mikart, LLC offers a competitive compensation program and comprehensive benefits package to our employees.

This position is currently accepting applications.

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