Purpose and Scope
The QA Specialist-Investigation Oversight is responsible for providing quality oversight for the Tolmar investigation process in accordance with company policies, standards, procedures, and CGMP. This position ensures deviations are thoroughly investigated, the root cause is determined, and appropriate corrective actions are identified and implemented based on associated risk to process, compliance or safety, identity, strength, purity, and quality (SISPQ). Additionally, the individual is responsible for overseeing and communicating metrics regarding deviations and CAPAs.
Essential Duties & Responsibilities

• Oversee and support deviations' prompt evaluation, investigation, closure, and follow-up.
• Review investigation reports for accuracy and completeness and assess impact to SISPQ.
• Review and approve SOPs, protocols/reports, change controls and investigations.
• Participate in the triage of events to determine criticality.
• Identify and implement opportunities for continuous improvements.
• Work with cross functional areas to determine root cause and appropriate Corrective/Preventive Actions.
• Work to establish appropriate ownership and timelines for CAPAs considering the amount of risk related to the event or issue.
• Develop, monitor, and report KPI metrics regarding deviations and CAPAs.
• Provide oversight and input to Trend Review Reporting and Lifecycle Review activities to identify and address process shifts and trends.
• Revise and update deviation SOPs to comply w/ cGMPs and other regulatory requirements.
• Perform RCA, Technical Writing, and Kepner Tregoe root cause analysis Training for the organization.
• Act as the SME and trainer for the Investigation/CAPA QMS module.
• Support inspections and audits of Tolmar Quality Systems and Operations.
• Represent the department in internal and external cross-functional teams.
• Serve as a Quality representative and oversight for continuous improvement projects.
• Perform other duties as assigned.

Knowledge, Skills & Abilities

• Must be proficient with pharmaceutical drug manufacturing processes, cGMPs and regulatory requirements including 21 CFR's, ICH and EU Annex 1.
• Independent, organized and able to lead others to meet deadlines.
• Ability to work in an independent and self-directed manner.
• Ability to work in a cross-functional team.
• Ability to influence, negotiate, manage conflict and collaborate.
• Ability to clearly communicate (oral & written) and work well with employees at all levels.
• Able to prepare written communications and communicate problems to management with clarity and accuracy.
• Ability to write procedures and reports clearly and accurately.
• Ability to recognize and group technical/scientific attributes and drive science-based decisions in most technical areas and to a deeper level in the specific job function.
• Ability to critically review investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
• Computer literacy in Microsoft Word, Excel and other MS Office programs.
• Recognized subject matter expert on quality assurance topics especially on Investigation processes.

Core Values

• The position is expected to operate within the framework of Tolmar's Core Values:
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success, and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company's success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelor's degree in scientific discipline required.
• Five or more years of experience in the pharmaceutical industry, minimum of three years working in QA preferable.
• Experience with authoring, execution and approval of Quality documentation including procedures, CAPAs and investigations. Experience with Kepner Tregoe root cause analysis preferred.
• Experience supporting inspections with FDA and other regulatory health authorities.

Working Conditions

• Core hours are from 8 AM - 5 PM Monday through Friday, with availability to work extended hours on evenings and/or weekends as necessary.

Compensation and Benefits

• Annual pay range $85,000 - $90,000
• Benefits information:https://www.tolmar.com/careers/employee-benefits

Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.
Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)