We have a current opportunity for a Contract QA Operation Consultant on a contract basis with Small molecules experiace. The position will be based in fully remote.
Please see the responsibilities below:
- Support the compliance oversight of manufacture and analysis of Drug Substance and Drug Products and packaging and labeling of clinical and commercial supplies at Contract Manufacturing Organizations (CMOs).
- Support of all aspects of drug manufacture through clinical development and into commercial phase.
- Review and approve Master Batch Record (MBR) in compliance with GMP regulations, and regulatory submissions.
- Review and approval of executed batch records, analytical raw data, stability protocols, reports and data, and other documents to enable drug substance and final drug product release and on-going evaluation ensuring batches as GMP compliant.
- Review and approval of validation protocols, raw data, and reports (Method, Process, Cleaning, etc.).
- Perform data integrity and compliance assessments including review against source documentation for regulatory submissions (e.g., Module 3)
- Support of the internal Change Control, Deviation, and Quality Investigation systems
- Compile/archiving MBRs, EBRS, and associated batch release documentation
- Support effective communication with CDMOs and deliver Quality objectives in accordance with project timeline.
Required Qualifications:
- B.S./M.S. degree in analytical chemistry or related life sciences discipline with at least 8 years of quality assurance experience in pharmaceutical product development.
- In-depth, working knowledge of cGMP compliance requirements for manufacturing and testing drug substance and drug product.
- In-depth, working knowledge of the drug development process and ICH requirements related to CMC activities in support of NDA and MAA registration.
- Experience in CDMO management and cross-functional collaboration skills.
- Ability to work successfully in a team/matrix environment and independently, as required.
- Ability to meet deadlines, demonstrate efficient and effective use of time, and handle multiple assignments simultaneously.
- Ability to convey both written and verbal information effectively and efficiently.
- Ability to follow procedures and perform assignments with a high degree of accuracy and careful attention to detail.
Contract:
- Start Date: ASAP
- Length: 6 months
- Hours: 40 Hours a week
- Location: fully remote - US based
- W2 worked only
