QC Investigation Reviewer

Core Hours: Monday - Friday, 8am-5pm

Purpose and Scope

The Quality Control Investigation Reviewer is a technical leader within the QC functional area with a primary role reviewing sample failures, deviations and procedure updates. Additionally, this role will facilitate collaboration between the Technical writers (investigators), QA reviewers and QC leadership to reach proper technical, compliant conclusions to OOS and non-conformance records. The role is intended for a person with significant industry experience who will contribute specific compliance knowledge and investigation skills to the QC group.

Essential Duties & Responsibilities

• Assume a high level, in-depth compliance leadership role in the QC laboratory for other analysts and peers. Such a role may entail training and mentoring of mid-level employees learning to write quality events, dissemination of specific knowledge to the QC group and technical leadership in specific projects as assigned.
• Review complex and challenging investigations and non-conformances that require a high level of expertise and in-depth knowledge in chemistry garnered from prior employment experience and/or academic training.
• Act as a primary technical resource for lab investigations and be a point of contact for QC and external departments.
• Review testing issues for compliance to procedures, review Out of Specifications and investigations for commercial, stability and developmental samples, as assigned by management.
• Provide scientific recommendations for CAPA and effectiveness reviews in the QC department.
• Work with leadership to assign CAPA implementation actions and resolution and effectiveness checks.
• Ensure compliance to all quality event timelines by facilitating progress with the authors and QA reviewers. Escalation to leadership, issues that threaten deadlines.
• Make scientific recommendations to management and other departments regarding Quality Control laboratory protocols and test procedures.
• Assist laboratory management in trending quality events.
• Assist the departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills.
• Upon delegation assume a supporting role to the management team for activities such as the issuance of COAs, review of Change Controls, test methods and specification PCOs and participate in project meetings.
• Provide support to the QC department for the evaluation and implementation of new technological innovations in laboratory automation systems, documentation systems and other technologies.
• Accountable for maintaining a positive atmosphere of teamwork, camaraderie, and respect towards co-workers.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Strong grasp of root cause analysis and 5 Whys methodology and CAPA.
• Understanding of ALCOA+ and data integrity principles.
• Effective communication and exceptional documentation and writing skills.
• Proven ability in cross functional groups to problem solve, gain consensus, and drive effective improvement.
• A demonstrated knowledge of fundamental chemistry pertaining to specific products and assays conducted in the Tolmar QC laboratory.
• Ability to grasp and enhance the technical expertise required for new products in the pipeline in order to support QC functions as per business needs.
• High level of proficiency in Quality Control laboratory procedures and testing techniques.
• Hands-on, operational and troubleshooting knowledge of analytical instrumentation within the QC department. Ability to evaluate and adapt new technologies that are to be introduced to the department based on business needs.
• Proficient knowledge of cGMP practices, regulatory and ICH guidelines.
• An excellent grasp on USP and other compendial methods.
• Knowledge of computer applications, including Microsoft Office.
• Experience in authoring technical reports.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.
• Ability to manage multiple projects concurrently and under tight time constraints.
• Strong abilities to teach and lead others to the correct conclusions, which satisfy scientific rational and compliance requirements in a multi-marketed pharma environment.

Core Values

The QC Investigation Reviewer is expected to operate within the framework of Tolmar's Core Values:

• Center on People: We commit to support the well-being of our patients. We are committed to treating our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
• Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.

Education & Experience

• BS in Chemistry, Biochemistry, Pharmaceutical Sciences or related field required. Masters or PhD preferred.
• Pharmaceutical cGMP laboratory work experience combined with BS: 8 or more years; Masters: 5 or more years or PhD: 2 or more years.
• Experience in the pharmaceutical industry to include experience with cGMP analytical testing of drug substances (DS) and Drug products (DP), preferably in high-volume Quality Control laboratory.

Working Conditions

• Working conditions are typical for an office environment in addition to a laboratory setting to include exposure to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.
• Must be adaptable to shifting priorities and operate with a sense of urgency while maintaining high quality in order to meet important timelines in a high throughput lab.
• Business demands may present a need to work extended hours.

Compensation and Benefits

• Annual pay range $110,000 - $115,000 depending on experience
• Bonus Eligible
• 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.