QC Investigation Specialist

This position will be a remote position with occasional onsite work required as necessary. Due to this, candidates must live within commuting distance of Windsor/Fort Collins, CO.

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

Purpose and Scope

The Quality Control Investigation Specialist is a technical leader within the QC functional area with a primary role in investigating sample failures and deviations from procedures. The role is intended for a person with significant industrial 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 new hires, dissemination of specific knowledge to the QC group and technical leadership in specific projects as assigned.
• Conduct complex and challenging investigations and non-conformances that need a high level of expertise and in-depth knowledge in chemistry garnered from prior employment experience or academic training.
• Act as a primary technical resource for lab investigations and be a point of contact for QC and external departments.
• Resolve testing issues including 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.
• Own CAPA implementation and resolution and effectiveness checks.
• 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.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes, and transfer of hazardous waste between lab procedure area, satellite accumulation, and storage. Respond to spills per CP 030-0202 Chemical Spill Response.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Strong grasp of root cause analysis and 5 Whys methodology.
• 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 trouble shooting 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.

Core Values

• The QC Investigation Specialist 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 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

• BS, MS or PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or related field.
• Pharmaceutical cGMP laboratory work experience combined with BS: 7 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 $95,000 - $105,000
• Bonus eligible
• Benefits information:

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.