The role involves managing compliance within the QC lab including change controls, CAPAs, document accuracy, and ensuring adherence to regulations.
Purpose and Scope
The Quality Control Technical Compliance Specialist is a technical and compliance role within the QC functional area. The primary functions related to this role include completing change controls, deviations, procedure updates, CAPAs and continuous improvement initiatives. Additionally, this role will facilitate collaboration between the investigations writers (investigators), document writers in other groups and QC leadership to reach proper technical decisions related to the types of records owned within QC.
Essential Duties & Responsibilities
The Quality Control Technical Compliance Specialist is a technical and compliance role within the QC functional area. The primary functions related to this role include completing change controls, deviations, procedure updates, CAPAs and continuous improvement initiatives. Additionally, this role will facilitate collaboration between the investigations writers (investigators), document writers in other groups and QC leadership to reach proper technical decisions related to the types of records owned within QC.
Essential Duties & Responsibilities
- Assume an in-depth compliance role in the QCC laboratory, including writing change controls, owning change actions, change assessments, CAPAs, deviations, routine document changes, and continuous improvement document changes.
- Work closely with the leadership team to redline documents and collaborate with the document writers in other departments to update QCC documents minimizing rework and additional rounds through the edit and approval cycle.
- Ensure accuracy and completeness of all documents and records, prior to routing through Veeva.
- Collaborate with the leadership team to ensure previous commitments and CAPAs remain in compliance with the revised requirements.
- Own and complete change controls related to method updates, specification updates, instrumentation upgrades or retirements, and changes to validated processes.
- Ensure all records and documents move through the process adhering to established procedure timelines, following up regularly with stakeholders and facilitating removal of any roadblocks which would prevent on-time completion.
- Serve as a point of contact for QCC and external departments related to external change assessments and change actions.
- Serve as a technical Subject Matter Expert (SME) for report reviews and approvals.
- Work closely with the investigation writers and management for CAPA discussions, while setting appropriate timelines for implementation and ensuring all dates are met.
- Work with leadership to complete CAPA implementation actions and effectiveness checks.
- Perform the quarterly trend deviation reports.
- Escalate any issues that threaten deadlines to leadership.
- Assist departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non-routine activities that require a higher level of scientific skills.
- Attend T3 Academy and drive completion of process improvement projects for the department.
- Upon delegation, assume a supporting role to the management team for activities such as the issuance of COAs, test methods and specifications, and participate in project meetings.
- Maintain 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, CAPA implementation and remediation.
- Strong understanding of ALCOA+ and data integrity principles.
- Proficient knowledge of cGMP practices, regulatory and ICH guidelines.
- High level of proficiency and in-depth knowledge of quality event records, Quality Control, laboratory procedures, and testing techniques, IT based systems and instruments.
- 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 per business needs.
- Hands-on, operational and troubleshooting knowledge of analytical instrumentation within the QC department.
- An excellent grasp on USP and other compendial methods.
- Knowledge of computer applications, including Microsoft Office.
- Experience in authoring or reviewing 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 pharma environment.
- Proficiency in quality risk management and operational excellence.
Core Values
- The QC Technical Compliance Specialist 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.
- Pharmaceutical cGMP laboratory work experience combined with BS: 6 or more years; Masters: 3 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 or off shifts.
- This position may be performed on a hybrid basis, with some work being performed on-site.
Top Skills
MS Office
Veeva
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