Quality Control Consultant

Quality Control Consultant

6 Month Contract (Potential to be extended)

Hourly Range – $80-90/hr (depending on experience)

Location:
Remote (East Coast Preferred)

Scientific Search has partnered with a growing publicly traded Pharmaceutical Company who has tasked us in finding a QC Consultant. This position will report into the Head of QC and work remotely anywhere on the East Coast.

• Oversees Quality Control testing of small molecule therapeutics in clinical development through commercial stage, including late-stage product specification setting and stability program oversight.
• CoA generation and approval.
• Collaborates cross-functionally and with external partners to ensure that quality control processes are aligned to the ensuring fit for purpose analytical methods, compliance, and alignment with business needs.
• Accountable for QC OOS/OOT investigations.
• Investigates, identifies root cause, and identifies CAPA for testing deviations.
• Authors monitoring and trend reports in support product release and stability.
• Directly manages reference standard and reference material program for assigned products; includes authoring and reviewing associated protocols and reports.
• Along with Analytical Development and Technical Operations, provides input for analytical and microbial method development and testing, technical services and commercial supply support to ensure timely testing. Ensures method transfer and phase appropriate qualification/validation of analytical methods as well as the transfer and validation of methods between testing sites.
• Supports QC Systems development, implementation and improvement in accordance with the requirements of cGMP.
• Authors, reviews, or approves SOPs, qualification/validation protocols and reports and change controls as related to Quality Control.
• Supports the establishment and publishing of Key Performance Indicators to track cGMP compliance for the Quality Control function. Captures metric information for use in continuous improvement of areas of responsibility.
• Participates in audits of the laboratories.

• Master’s Degree and 5+ years’ experience OR Bachelor’s degree with 10+ years of experience.
• QC lab management experience.
• Thorough knowledge of Stability.
• Experience setting specifications and product expirations.
• Deep experience with QC OOS/OOT investigations.
• Well versed in various analytical and bioanalytical techniques for small molecule therapeutics.
• Working knowledge of quality systems, US regulatory requirements (21 CRF Part 11/210/211,820), and Guidance documents.
• Working knowledge of analytical method validation and methods transfer.
• Thorough knowledge of GMPs/cGMPs, SOPs and quality control processes.
• Thorough knowledge of technical writing for NDA, BLA, IND, CMC sections.
• Experience with equipment qualification and validation.
• Knowledge of data management tools and statistical process control, and data integrity requirements and expectations.
• Experience with ELN and LIMS desirable.
• Proficient in MS Word, Excel, Power Point and other applications.
• Self-motivated, detail-oriented, and willing to accept temporary responsibilities.
• Demonstrated expertise in commercial manufacture.
• Ability to communicate and work in a self-guided manner with internal and external scientific/technical personnel, and all other cross-functions.
• Comfortable in an adaptable small company environment with minimal direction and able to adjust workload based upon changing priorities.

We’d love to see your resume, but we don’t need it to have a conversation. Send us an email to and tell me why you’re interested. Or, feel free to email your resume. Please include Job#19761
.

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