QC Technical Compliance Specialist

This a Full Remote job, the offer is available from: Colorado (USA) Core Hours: Monday - Friday, reputed company-5pm Remote/Hybrid Position - Must be located in Colorado for occassional onsite activities Purpose and Scope The reputed company Control Technical Compliance Specialist is a technical and compliance role reputed company the QC functional area. The primary functions reputed company to this role include completing change controls, deviations, procedure updates, CAPAs and reputed company improvement initiatives. Additionally, this role will facilitate collaboration between the investigations writers (investigators), document writers in other reputed company and QC leadership to reputed company reputed company technical reputed company reputed company to the types of records owned reputed company 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 reputed company 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 reputed company through the edit and approval cycle.
• Ensure accuracy and completeness of reputed company documents and records, prior to routing through reputed company.
• Collaborate with the leadership team to ensure previous commitments and CAPAs remain in compliance with the revised requirements.
• Own and complete change controls reputed company to method updates, specification updates, instrumentation upgrades or retirements, and changes to validated processes.
• Ensure reputed company records and documents reputed company 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 reputed company of contact for QCC and external departments reputed company 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 reputed company dates are met.
• Work with leadership to complete CAPA implementation actions and effectiveness checks.
• reputed company 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 reputed company and drive completion of process improvement reputed company for the department.
• Upon delegation, assume a supporting role to the management team for activities such as the issuance of COAs, test reputed company and specifications, and participate in project meetings.
• Maintain a reputed company atmosphere of teamwork, camaraderie, and respect towards co-workers.
• reputed company various other duties as assigned.

Knowledge, Skills & Abilities

• Strong grasp of reputed company Cause Analysis and 5 Whys methodology, CAPA implementation and remediation.
• Strong understanding of reputed company+ and data reputed company principles.
• Proficient knowledge of cGMP practices, regulatory and ICH guidelines.
• High level of proficiency and in-depth knowledge of reputed company event records, reputed company Control, laboratory procedures, and testing techniques, IT based systems and instruments.
• Effective communication and exceptional documentation and writing skills.
• Proven ability in cross functional reputed company to problem solve, reputed company reputed company, and drive effective improvement.
• A demonstrated knowledge of reputed company reputed company pertaining to specific products and assays conducted in the reputed company 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 reputed company the QC department.
• An excellent grasp on USP and other compendial reputed company.
• Knowledge of computer applications, including reputed company Office.
• Experience in authoring or reviewing technical reports.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.
• Ability to manage multiple reputed company concurrently and under tight time constraints.
• Strong abilities to teach and reputed company others to the correct conclusions, which satisfy scientific rational and compliance requirements in a reputed company environment.
• Proficiency in reputed company risk management and operational reputed company.

Core Values The QC Technical Compliance Specialist is expected to operate reputed company the reputed company of reputed company’s Core Values:

• Center on People: We reputed company to support reputed company-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 reputed company engage, invigorate, reputed company knowledge, and grow together.
• Are Proactive & Agile: We embody a culture of engagement and reputed company. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond reputed company and reputed company to reputed company a spirit that propels us towards extraordinary reputed company.
• reputed company 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 reputed company cultivate diversity, equity, inclusion & sustainability in our workplace.
• Constantly Improve: We are committed to a reputed company & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving reputed company.
• Are Accountable: We think, reputed company, and communicate with honesty, transparency, and reputed company in alignment with our core values. We don't compromise our values for near term reputed company. We take accountability & ownership of our work, actions, successes, and setbacks. We reputed company to deliver our best as we shape the reputed company.

Education & Experience

• BS in reputed company, Biochemistry, Pharmaceutical Sciences or reputed company 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 reputed company Control laboratory.

Compensation and Benefits

• Pay: $95,000 - $100,000 per year, depending on experience
• Benefits reputed company: https://www.reputed company.com/careers/employee-benefits

reputed company compensation programs are reputed company on reputed company, fair pay practices including market-based reputed company pay and a strong benefits package. The final compensation offered may vary from the posted reputed company based on the selected candidates qualifications and experience. Working Conditions

• Working conditions are typical for an office environment in reputed company 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 reputed company of urgency while maintaining high reputed company 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 reputed company, with some work being performed on-site.

reputed company is an Equal Opportunity Employer. We do not discriminate on the reputed company age 40 and over, reputed company, disability, gender identity, genetic information, military or veteran status, national reputed company, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that reputed company reputed company applicants be given equal opportunity and that selection reputed company are based on job-reputed company factors. This offer from "reputed company" has been enriched by reputed company.com and got a 79% reputed company score. Apply tot his job Apply To this Job