Novartis Group Companies
QC Specialist Tech Resources & Compliance
Novartis Group Companies, Durham, North Carolina, United States, 27713
Job Description Summary-This position will support activities within the Quality Control department, with a focus on technical items for QC, compliance and continuous improvement. This role will utilize strong cGMP understanding and scientific knowledge to perform Change Controls, investigations, technical review, etc. This role requires strong project management and communication skills to coordinate and implement cross-functional projects, ensuring timely and compliant execution. This role is based 100% on-site.
Novartis is unable to pay relocation for this role so please ensure you are able to work from this location.
Job DescriptionKey Responsibilities:Authors QC investigations and meets all targets for timely closure and CAPA completion.Coordinate with Quality to ensure compliance and continuous improvement in the QC labs.Coordinates change control for method related changes.Perform technical review of QC assays for cGMP release and characterization testing, including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC-ELSD, HPLC-MS), AUC, compendial assays (Bioburden, pH) and electrophoresis (CE, Western Blot).Authors technical documents such as Protocols / Reports.Works with the greater QC team to ensure updates of SOP, WP, Form, etc.Supports regulatory inspections.Capable of delivering to assigned work schedule with attention to detail and accuracy.Perform laboratory testing as required.Other duties QC is responsible for, as assigned.
Requirements:Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years' experience in GMP environment.Excellent interpersonal, verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.Proven ability to work effectively in a team environment. Collaborates cross functionally with other departments to achieve site goals.Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking, troubleshooting and problem-solving skills.Normally receives general instructions on routine work, detailed instructions on new projects or assignments.Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
#LI-Onsite
EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to
call
and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
careers/careers-research/notice-all-applicants-us-job-openings
Salary Range$84,000.00 - $126,000.00
Skills DesiredAgility, Audit Management, Business Partnering, Change Control, Continuous Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise
Novartis is unable to pay relocation for this role so please ensure you are able to work from this location.
Job DescriptionKey Responsibilities:Authors QC investigations and meets all targets for timely closure and CAPA completion.Coordinate with Quality to ensure compliance and continuous improvement in the QC labs.Coordinates change control for method related changes.Perform technical review of QC assays for cGMP release and characterization testing, including but not limited to cell-based methods (potency, AA), PCR (ddPCR, qPCR), Immunoassays (ELISA), chromatography (HPLC-UV, HPLC-ELSD, HPLC-MS), AUC, compendial assays (Bioburden, pH) and electrophoresis (CE, Western Blot).Authors technical documents such as Protocols / Reports.Works with the greater QC team to ensure updates of SOP, WP, Form, etc.Supports regulatory inspections.Capable of delivering to assigned work schedule with attention to detail and accuracy.Perform laboratory testing as required.Other duties QC is responsible for, as assigned.
Requirements:Bachelor's degree in scientific disciplines such as Biochemistry, Biology, Microbiology or related field with 5 years' experience in GMP environment.Excellent interpersonal, verbal and written communication skills with strong technical writing experience required. Previous investigation experience a plus.Proven ability to work effectively in a team environment. Collaborates cross functionally with other departments to achieve site goals.Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.Exercises judgment within defined procedures and practices to determine appropriate action including critically thinking, troubleshooting and problem-solving skills.Normally receives general instructions on routine work, detailed instructions on new projects or assignments.Self-motivated, detail-oriented, and willing to accept temporary responsibilities outside of core duties.
#LI-Onsite
EEO Statement:The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to
call
and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
careers/careers-research/notice-all-applicants-us-job-openings
Salary Range$84,000.00 - $126,000.00
Skills DesiredAgility, Audit Management, Business Partnering, Change Control, Continuous Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise