Ivory Systems | Senior Quality Assurance Specialist | philadelphia, pa
1 week ago
JOB SUMMARY
The Manager (Consultant), R&D Quality supports Research and Development by supporting the quality needs of the R&D Department with focus on pre-commercial GMP products and projects, working directly with clients and Project Managers to ensure positive customer interactions. The Manager, R&D Quality will also work with members of the Quality Operations department to monitor and approve R&D and PRD batch activities.
RESPONSIBILITIES AND LEARNING OPPORTUNITIES
- Ensures Quality Systems compliance (CAPA, Non-Conformance, Trending, Data Integrity, Customer Complaints, Change Control, etc.) and drives improvements specifically for R&D
- Partners with Project Management to ensure a Quality voice and a high level of client support for ongoing R&D projects; including but not limited to participation in project meetings, and follow-up documentation
- Provide guidance and ensure corrective and preventive actions are adequately and timely implemented and monitor their closure and effectiveness
- Support the R&D department in the evaluation of department SOP’s to drive efficiency and quality by design
- Oversees the review and approval of development batch records for non-commercial GMP batches (clinical batches, tech transfer batches, for example)
- Reviews and approves Design of Experiment and Critical Process Parameter Reports
- Reviews and approves all quality related documentation produced by R&D, including sampling protocols, stability protocols, test method qualification and validation reports.
- Reviews and approves investigations generated by R&D
- Is a backup resource to the QA team that focuses on commercial product as needed by the Quality Director.
- Participates in internal audits of the R&D department
- Participates in developmental customer internal and external planning sessions
- Interact with Customer’s Quality associates to fulfill client needs
- Participate in Customer/Regulatory audits as needed
- Reviews and approves investigations, assisting with determining root cause and recommends & implements corrective, preventive actions
- Collaborate with all departments within the company as required
- Ensure facility adherence to cGMP’s and SOP’s with special focus on R&D
- Other duties as assigned
REQUIRED SKILLS AND QUALIFICATIONS
- BS/BA degree in a Scientific discipline from a four-year accredited university or college.
- 5+ years’ of related experience preferred.
- Advanced knowledge GMPs specifically clinical GMP’s
- Understanding of Quality Systems pertaining to a bulk pharmaceutical, solid oral dosage manufacturing and packaging environment is preferred.
- Strong communication skills, both written and verbal.
- Operational knowledge of European GMPs.
- Able to prioritize duties and manage multiple activities from start to finish with minimal supervision.
- Exceptional attention to detail and excellent organizational skills.
-
Senior Quality Assurance Specialist
1 week ago
Philadelphia, United States Ivory Systems Full timeJOB SUMMARYThe Manager (Consultant), R&D Quality supports Research and Development by supporting the quality needs of the R&D Department with focus on pre-commercial GMP products and projects, working directly with clients and Project Managers to ensure positive customer interactions. The Manager, R&D Quality will also work with members of the Quality...
-
philadelphia, United States Proclinical Staffing Full timeAssociate Director, Quality Assurance - Permanent - Philadelphia, PAProclinical is working alongside a pharmaceutical company seeking an Associate Director, Quality Assurance to join their growing team! Primary Responsibilities:The successful candidate will lead a team of quality professionals, supporting the routine release of raw materials, critical...
-
philadelphia, United States Proclinical Staffing Full timeAssociate Director, Quality Assurance - Permanent - Philadelphia, PAProclinical is working alongside a pharmaceutical company seeking an Associate Director, Quality Assurance to join their growing team! Primary Responsibilities:The successful candidate will lead a team of quality professionals, supporting the routine release of raw materials, critical...
-
Quality Assurance Engineering Specialist
3 months ago
Philadelphia, United States Iovance Biotherapeutics, Inc. Full timeQuality Assurance Engineering Specialist will provide Quality Engineering oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Quality Assurance Engineering Specialist will be responsible for supporting the design, installation...
-
Quality Assurance Engineering Specialist
3 weeks ago
Philadelphia, United States Iovance Biotherapeutics, Inc. Full timeQuality Assurance Engineering Specialist will provide Quality Engineering oversight and support for the development and operations of a commercial scale cGMP cell therapy manufacturing and laboratory facility along with associated software applications. This Quality Assurance Engineering Specialist will be responsible for supporting the design, installation...
-
Travel MRI Technologist Contract in Philadelphia, PA
2 months ago
Philadelphia, United States Sunbelt Staffing Full timeJob DescriptionJob DescriptionMinimum 1+ years imaging experience required.Job Title: Travel MRI TechnologistLocation: Philadelphia, PAType: Full-Time Contract PositionDuration: 13 WeeksJob Description:Sunbelt Staffing is seeking a skilled and dedicated Travel MRI Technologist for a 13-week contract position in Philadelphia, PA.Why Philadelphia,...
-
LPNT Travel
2 weeks ago
Philadelphia, United States Kindred Hospital Philadelphia Full timeDetailsClient Name Kindred Hospital Philadelphia Job Type Travel Offering Allied Profession Therapy Specialty PT Job ID 29277493 Job Title LPNT Travel (Cortes) - Physical Therapist (PT) - KH Philadelphia - Philadelphia, PA Weekly Pay $2202.0 Shift DetailsShift Day - 8x5 - 08AM Scheduled Hours 40 Job Order DetailsStart Date 11/18/2024 End Date 02/16/2025...
-
LPNT Travel
1 week ago
Philadelphia, United States Kindred Hospital Philadelphia Full timeDetailsClient Name Kindred Hospital Philadelphia Job Type Travel Offering Allied Profession Therapy Specialty PT Job ID 29277493 Job Title LPNT Travel (Cortes) - Physical Therapist (PT) - KH Philadelphia - Philadelphia, PA Weekly Pay $2202.0 Shift DetailsShift Day - 8x5 - 08AM Scheduled Hours 40 Job Order DetailsStart Date 11/18/2024 End Date 02/16/2025...
-
LPNT Travel
3 weeks ago
Philadelphia, United States Kindred Hospital Philadelphia Full timeDetails Client NameKindred Hospital Philadelphia Job TypeTravel OfferingAllied ProfessionTherapy SpecialtyPT Job ID29277493 Job TitleLPNT Travel (Cortes) - Physical Therapist (PT) - KH Philadelphia - Philadelphia, PA Weekly Pay$2202.0 Shift Details ShiftDay - 8x5 - 09AM Scheduled Hours40 Job Order Details Start Date11/18/2024 End Date02/16/2025 Duration13...
-
LPNT Travel
3 weeks ago
Philadelphia, United States Kindred Hospital Philadelphia Full timeDetails Client NameKindred Hospital Philadelphia Job TypeTravel OfferingAllied ProfessionTherapy SpecialtyPT Job ID29277493 Job TitleLPNT Travel (Cortes) - Physical Therapist (PT) - KH Philadelphia - Philadelphia, PA Weekly Pay$2202.0 Shift Details ShiftDay - 8x5 - 09AM Scheduled Hours40 Job Order Details Start Date11/18/2024 End Date02/16/2025 Duration13...
-
Quality Assurance
3 weeks ago
Philadelphia, United States Federal Reserve Bank of Philadelphia Full timeCompanyFederal Reserve Bank of PhiladelphiaWhen you join the Federal Reserve-the nation‘s central bank-you‘ll play a key role, collaborating with leading tech professionals to strengthen and protect our economic, financial and payments systems. We dedicate more than $1 billion to technology each year to support the Federal Reserve and our economy, and...
-
philadelphia, United States Amtex Systems Inc. Full timeJob DescriptionJob Title: System Analyst IIIClient Location: Philadelphia, PAHours: Full-time (40 hours per week)Key ResponsibilitiesPerform advanced operational support, maintenance, and configuration for assigned systems.Troubleshoot and resolve data and system issues of high complexity.Lead small teams and initiatives to meet departmental and...
-
philadelphia, United States Amtex Systems Inc. Full timeJob DescriptionJob Title: System Analyst IIIClient Location: Philadelphia, PAHours: Full-time (40 hours per week)Key ResponsibilitiesPerform advanced operational support, maintenance, and configuration for assigned systems.Troubleshoot and resolve data and system issues of high complexity.Lead small teams and initiatives to meet departmental and...
-
philadelphia, United States Philadelphia Gas Works Full timePhiladelphia Gas Works Looking for a challenge and ready to light up your career? Free Health Insurance Options– Free Dental Insurance – Flex Spending - Commuter Benefits - Pension Plan – Free Parking – Wellness Programs – Onsite Gyms – Tuition Assistance- PSLF Eligible Employer- Parental Leave - Hybrid Work EnvironmentPGW does not provide...
-
Philadelphia, United States Sunbelt Staffing Full timeJob DescriptionJob DescriptionMinimum 1+ years imaging experience required.Job Title: Travel MRI TechnologistLocation:Philadelphia, PAType: Full-Time Contract PositionDuration: 13 WeeksJob Description:Sunbelt Staffing is seeking a skilled and dedicated Travel MRI Technologist for a 13-week contract position in Philadelphia, PA.Key Responsibilities:Perform a...
-
Senior Associate, Mechanical Engineering
23 hours ago
Philadelphia, United States L3 Technologies Full timeJob Title: Senior Associate, Mechanical Engineer (New Grad - Philadelphia, PA) Job Code: 18719 Job Location: Philadelphia, PA Job Description: Under general supervision, the Sr. Associate, Mechanical Engineer is responsible for assisting lead mechanical engineers in design/analysis to support mechanical layout of power equipment and other Navy based...
-
Quality Assurance Clerk
4 weeks ago
Philadelphia, United States PeopleShare Inc Full timePeopleShare is currently hiring for a Quality Assurance Clerk in Philadelphia, PA! Apply Below! PeopleShare is looking to hire a candidate for a Quality Assurance Clerk for a well-established company in Center City Philly. This company values teamwork, communication, and feedback. The average tenure of employees at this company is 15-18 years, mainly in...
-
Quality Assurance Clerk
4 weeks ago
Philadelphia, United States PeopleShare Inc Full timePeopleShare is currently hiring for a Quality Assurance Clerk in Philadelphia, PA! Apply Below! PeopleShare is looking to hire a candidate for a Quality Assurance Clerk for a well-established company in Center City Philly. This company values teamwork, communication, and feedback. The average tenure of employees at this company is 15-18 years, mainly in...
-
Quality Assurance Clerk
2 months ago
Philadelphia, United States PeopleShare Inc Full timePeopleShare is currently hiring for a Quality Assurance Clerk in Philadelphia, PA! Apply Below! PeopleShare is looking to hire a candidate for a Quality Assurance Clerk for a well-established company in Center City Philly. This company values teamwork, communication, and feedback. The average tenure of employees at this company is 15-18 years, mainly in...
-
Quality Assurance Clerk
4 weeks ago
philadelphia, United States PeopleShare Inc Full timePeopleShare is currently hiring for a Quality Assurance Clerk in Philadelphia, PA!Apply Below!PeopleShare is looking to hire a candidate for a Quality Assurance Clerk for a well-established company in Center City Philly.This company values teamwork, communication, and feedback. The average tenure of employees at this company is 15-18 years, mainly in part...
