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Minaris Advanced Therapies · 1 day ago

Quality Assurance Associate II

Allendale, NJ

Full-time

Onsite

Entry Level

1+ years exp

Minaris Advanced Therapies is a global leader in cell and gene therapy development, manufacturing, and testing. The Quality Assurance Associate II is responsible for performing Quality Assurance activities under supervision, including document management, review of QC data, and material releases to support Quality Systems and client procedures.

BiotechnologyHealth CareManufacturing

H1B Sponsor Likely

Responsibilities

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

Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing

Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)

Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing

Release raw material in ERP system as well as on paper

Perform Accessioning of incoming Apheresis

Review Batch record and disposition material of finished product to client

Provides information for Out of Specification and deviations to investigator

Performs line clearance prior to manufacturing operations begins

Other duties as assigned

Qualification

GMP regulationsCGMP complianceBiologics manufacturingDocument managementAnalytical skillsMicrosoft OfficeCommunication skillsProblem-solving skillsTime managementTeamwork

Required

Regular and reliable attendance on a full-time basis

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

Ensures that all procedures and processes meet internal quality standards as well as external regulations specific to pre-clinical, clinical and commercial manufacturing

Read, understand and follow all cGMP and cGTP documentation for Quality System Functions (SOPs,WIs,etc.)

Maintain cGMP and cGTP compliance for all aspects of pre-clinical, clinical and commercial manufacturing

Release raw material in ERP system as well as on paper

Perform Accessioning of incoming Apheresis

Review Batch record and disposition material of finished product to client

Provides information for Out of Specification and deviations to investigator

Performs line clearance prior to manufacturing operations begins

Other duties as assigned

Relevant computer skills (Microsoft Office, Outlook)

Detail-oriented and organized

Analytical and problem-solving skills

Good written and oral communication skills

Ability to multi-task, prioritize, time manage and be adaptable

Flexible and able to adapt to company growth and evolving responsibilities

Ability to work independently and with a team

BS or higher education degree in a scientifically related field

Experience in a biologics or biotechnology company (1 -3 years)

Preferred

Working knowledge and technical understanding of the aseptic manufacture of biologics preferred

Working knowledge of GMP and TCTP regulations

Experience in reviewing GMP/GCTP related documents (validations/qualifications reports, SOPs, etc.)

Benefits

Medical insurance

Vision insurance

Dental insurance

401(k)

Paid time off

Tuition assistance

And more

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

Represents job field similar to this job

Trends of Total Sponsorships

2024 (1)

2022 (1)

2021 (1)