- Lead the effort to work with Porton quality team to establish and improve quality management systems for Porton USA to support late phase/commercial GMP manufacturing and testing with a focus on QC compliance.
- Work with Quality Control team to improve QC GMP compliance program.
- In collaboration with Porton QA/IT and QC to establish and execute a Data Integrity Program.
- Provide strategic support for the GMP facility expansion and validation of all GMP systems including facilities, utilities, equipment, cleaning verification, methods, and instruments.
- Provide quality oversight for the manufacture, testing, and release of APIs and intermediates in accord with cGMP regulations and related FDA/ICH guidelines.
- Promote compliance with cGMP regulations. Present and coordinate GMP training sessions.
- Support management and maintenance of the SOP and Document Control system.
- Author, review, update, and approve quality documents, validation protocols and reports, specifications, and procedures as needed.
- Conduct timely review and approval of process and analytical records.
- Assist in deviation and OOS investigations to ensure comprehensive investigations into the root cause, impact assessment and corrective and preventive actions , and completion on a timely manner.
- Ensure that change control is enforced for critical systems, procedures, and specifications.
- Participate in internal audits to assess GMP compliance and identify potential gaps or training needs. Develop and implement corrective actions to address observations.
- Support for client audits and regulatory inspections. Track completion of post-audit action items.
- Work with clients to develop material release tests and specifications for materials supplied by J‐STAR.
- Help ensure that client project needs, requirements, and timelines are communicated to, and coordinated between, GMP Operations and Quality Control.
- Respond to client inquiries and provide information and updates as needed and appropriate to support regulatory filings.
- ≥ 3 years of experience within the pharmaceutical/biotechnology industry or CDMO industry is required.
- ≥ 3 years of experience in small molecule cGMP processing, analysis and/or release testing is required.
- ≥ 3 years of experience in process chemistry is preferred, but not required.
- BA/BS degree in chemistry, chemical engineering or pharmaceutical sciences is required.
- Proven track record of setting and meeting aggressive targets and timely execution of objectives.
- Excellent written, verbal and communication skills.
- Ability to prioritize and manage numerous projects simultaneously.
- Ability to interact in an effective and appropriate manner with diverse population sets.
- Ability to communicate candidly, clearly and timely.
- Experience in working on, positively contributing to, and leading teams.
- Proficient in MicrosoftOfficeTMand other job-related software and applications.
- Bilingual in English and Mandarin is preferred.
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Referral program
- Vision insurance
- This position requires working at both the Cranbury and South Plainfield locations. Will you be able to reliably commute to both locations?
- small molecule cGMP processing: 3 years (Preferred)
- pharmaceutical/biotechnology industry or CDMO industry: 3 years (Preferred)
- GMP Lab Quality assurance: 3 years (Preferred)
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Description
Job description
Job Description– Quality Assurance
Porton Pharma Solutions Ltd. is a leading global provider of comprehensive process R&D and manufacturing services to the pharmaceutical industry. We specialize in offering end-to-end solutions for small molecule APIs, dosage forms, and biologics. With a focus on innovation and customer satisfaction, we are committed to delivering high-quality products and services that meet the industry's evolving needs. Our experienced team of experts works tirelessly to ensure every project is completed on time, within budget, and to the highest possible standards. Whether you need support with drug development, manufacturing, or regulatory compliance, Porton Pharma Solutions Ltd. has the expertise and capabilities to help you achieve your goals.
Our organization is actively seeking a highly skilled and experienced Quality Assurance Specialist or Manager. The ideal candidate should possess a strong understanding of industry regulations and requirements, with the ability to provide expert guidance on all matters related to quality assurance, exceptional attention to detail, and a keen eye for identifying potential issues
Position Title: Quality Assurance
Job Grade: Quality Assurance Specialist or Manager
Direct Report: Quality Assurance Director
Responsibilities:
Additional Responsibilities:
Requirements:
Job Type: Full-time
Benefits:
Application Question(s):
Experience:
Work Location: In person
