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Minaris Advanced Therapies · 2 months ago

QA Testing - Quality Assurance Compliance Specialist I

Advanced Therapies, 4751 League Island Blvd., Philadelphia, Pennsylvania, United States of America

Full-time

Onsite

Entry, Mid Level

2+ years exp

Minaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing. The Quality Assurance Compliance Specialist I will review laboratory testing data in accordance with regulatory standards and provide guidance for quality-related issues while ensuring compliance with established procedures.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

Compiles and reviews raw data and test results, including Final Reports and COAs, in accordance with cGMP, cGLP, Code of Federal Regulations (CFR) and internal procedures in an efficient and timely manner. Assure that any observations/deviations are properly investigated and explained

Performs timely review of complex study files, such as: Assay Validation and Qualifications

Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (e.g., ICH, ISPE, etc.)

Reviews and approves document change requests

Perform QA inspections of Laboratories

Participate/lead in Client audits

Perform timely review of Viral Clearance data

Perform review and approval of Laboratory Investigations (OOS) and Nonconforming events

Write nonconforming events or deviations if necessary

Write and revise SOPs as necessary

Perform trend analysis and report results for quality metrics

Assists Management in the training of new hires

Participate in quality and process improvement initiatives and project teams

Attend meetings as QA representative

Backup for QA supervision/management

Works on routine assignments per written procedures, where ability to recognize deviation from accepted practice is required

Normally receives minimal instructions on routine work and detailed instructions on new assignments

Ability to work in a team environment and independently as required

Regular and reliable attendance on a full-time basis

Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices

Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture

Qualification

CGMP complianceQA inspectionsLaboratory InvestigationsSOP writingData analysisMicrosoft OfficeEnglish proficiencyTeamworkCommunication skillsProblem-solvingAttention to detail

Required

At least 2-5 years of relevant laboratory and/or QA experience or equivalent

Bachelors' degree in a Science related field

Ability to accomplish the duties described through the use of appropriate computer equipment and software (Microsoft Word, Excel, Outlook, and Access)

Ability to accurately and reproducibly perform arithmetic, algebraic and geometric calculations

Ability to record data accurately and legibly

Ability to use judgment as dictated by the complexity of the situation

Ability to understand and follow verbal or demonstrated instructions

Ability to work effectively as part of a team and to exhibit effective interpersonal skills

Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication

Proficient in Oral & Written communication skills

Need to be able to read, write and understand English

Regular and reliable attendance on a full-time basis

Embodies Minaris Advanced Therapies values and aligns daily actions with department and company culture

Benefits

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid time off

Tuition assistance

Company

Minaris Advanced Therapies

Minaris Advanced Therapies is a global cell and gene therapy (CGT) CDMO and a multimodality biosafety testing provider.

Founded in 1999

Allendale, New Jersey, USA

1001-5000 employees

https://www.rm.minaris.com

H1B Sponsorship

Minaris Advanced Therapies has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2024 (1)

2022 (1)

2021 (1)