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Form of workThis is what you will do:
Clinical QC Specialist is responsible for perfoming assigned tasks in support of maintaining overall GMP quality and compliance in the Clinical Quality Control laboratory within Analytical Development Quality Control Department. The specialist will help identify and implement quality requirements under the direction of the Senior CQC Compliance Specialist; disseminating policies, procedures, assisting in internal audits, and performing compliance related tasks within a regulated EDMS. Additionally, this candidate will be responsible for equipment maintenance including maintaining calibration schedules and equipment qualification packages, analyst training curriculum oversight, change controls, deviations, CAPAs and audit responses.
You will be responsible for:
Job Duties and Responsibilities:
You will need to have:
Essential Qualifications:
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Preferred Qualifications.
In-person statement for 4 days in the office:
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Date Posted
31-Oct-2023
Closing Date
29-Dec-2023
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
Clinical QC Specialist is responsible for perfoming assigned tasks in support of maintaining overall GMP quality and compliance in the Clinical Quality Control laboratory within Analytical Development Quality Control Department. The specialist will help identify and implement quality requirements under the direction of the Senior CQC Compliance Specialist; disseminating policies, procedures, assisting in internal audits, and performing compliance related tasks within a regulated EDMS. Additionally, this candidate will be responsible for equipment maintenance including maintaining calibration schedules and equipment qualification packages, analyst training curriculum oversight, change controls, deviations, CAPAs and audit responses.
You will be responsible for:
Job Duties and Responsibilities:
- Working in a fast-paced environment where product development supports unmet needs of patients with rare diseases.
- Responsible for generating, reviewing, providing assessments and maintaining out of specification (OOS) reports, deviation reports, CAPAs and Change Controls for Analytical Sciences cGxP operations as directed.
- Oversee equipment qualification program (i.e. System implementation, upgrades, oversee calibration and maintenance, calendar, service, review, approve and maintain equipment binders and log books)
- Assist with QA audits and design correction action to observations as assigned
- Work with direct management to maintain the training matrix of ADQC
- Review of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements; presents findings
- Work with direct management to identify opportunities for improvement in systems and processes as well as makes recommendations for effective changes to ensure compliance with cGMP
- Write and review methods, SOPs, qualification and validation protocols and reports, and technical reports as assigned.
- Compile data and information related to assay and instrument performance.
- Maintain knowledge of current scientific principles and theories, train other lab personnel, and provide troubleshooting assistance as assigned in areas of competence.
- Ensure training is current for all job functions performed. Attend all required company training.
- Perform other related duties as assigned
- Global role requiring domestic and international travel (~0-5%)
You will need to have:
Essential Qualifications:
- A successful candidate will have a B.S. degree with 2-5 years of experience working in cGMP setting
- Strong verbal and written communication skills
- A broad knowledge of Pharmaceutical Quality Assurance, regulatory compliance or quality control inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations.
- Proficient with various MS Office programs, including Word, Excel, Outlook, PowerPoint, database management and statistical analysis
- Effectively organize and manage work responsibilities. Good time and project management skills with the ability to multi-task.
- Experience with documentation and quality systems.
- Knowledge of pharmaceutical/biotechnology process
The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without an accommodation to: use a computer; engage in communications via phone, video, and electronic messaging; engage in problem solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
Preferred Qualifications.
- Previous experience with Trackwise
- Previous experience with Veeva Vault eDMS
- Previous experience with ValGenesis
- Previous experience with Laboratory Information Systems (LIMS).
- Proficient with various MS Office programs, including Word, Excel, Outlook, and PowerPoint as well as SAS JMP statistical software.
In-person statement for 4 days in the office:
Expectation of working in the office 4 days a week statement: When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working give us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of four days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.
AstraZeneca requires all US employees to be fully vaccinated for COVID-19 but will consider requests for reasonable accommodations as required by applicable law.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.
Date Posted
31-Oct-2023
Closing Date
29-Dec-2023
Alexion is proud to be an Equal Employment Opportunity and Affirmative Action employer. We are committed to fostering a culture of belonging where every single person can belong because of their uniqueness. The Company will not make decisions about employment, training, compensation, promotion, and other terms and conditions of employment based on race, color, religion, creed or lack thereof, sex, sexual orientation, age, ancestry, national origin, ethnicity, citizenship status, marital status, pregnancy, (including childbirth, breastfeeding, or related medical conditions), parental status (including adoption or surrogacy), military status, protected veteran status, disability, medical condition, gender identity or expression, genetic information, mental illness or other characteristics protected by law. Alexion provides reasonable accommodations to meet the needs of candidates and employees. To begin an interactive dialogue with Alexion regarding an accommodation, please contact accommodations@Alexion.com. Alexion participates in E-Verify.
