Qa Qc Engineer

Amick Brown is seeking an experienced QA/QC ENGINEER 3 for our direct client.

Estimated pay range: $46.76-58.46per client contract and candidate skills, experience and work location.

• The role is responsible for providing quality assurance oversight to the cross-functional CMC team, and third party contractors, ensuring compliance with cGMP requirements (US and EU), in-house SOPs and standards for clinical drug substance / drug products.
• The individual will review and approve master and executed batch records for small molecule API and sterile DP.

Essential Functions:

• Provide quality assurance oversight for production, testing and release of clinical products manufactured by CMOs
• Execute per documented processes to ensure high quality products and compliance with cGMPs
• Organize and prioritize group tasks, provide job skills training and mentoring of personnel as needed
• Review and approve documents such as standard operating procedures, manufacturing batch records, packaging and labeling records, sampling plans, test methods, specifications, stability protocols and reports.
• Act as a compliance resource to provide guidance and assistance towards resolution of moderate to complex deviations, quality investigations, lab investigations, CAPAs and change control; review and approve quality system documents related to manufactured products
• Ensure consistent quality standards across multiple CMOs and CTLs

Preferred Experience:

• Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry with at least 5 of those years in QA or closely related field
• Comprehensive expertise and working knowledge of 21 CFR Parts 11, 210, 211, EudraLex Volume 4 and related Annexes, and ICH guidance documents

Preferred Education:

• BA or equivalent in biology, chemistry or related science

Preferred Additional Skills (i.e., Computer):

• Excellent interpersonal and verbal and written communication skills
• Experience in aseptic processes is highly desirable and knowledge of small molecules is required
• Ability to manage multiple clinical projects; experience with process validations is desired
• Solid to expert working knowledge and understanding of US and international (e.g. EU, ICH) cGMP regulations, procedures and guidelines that govern manufacturing, quality control and quality assurance of drugs produced for clinical trial investigation
• Attention to detail with an ability to perform critical review of various types of technical documents
• Proficient with commonly used word processing, database systems and other software

Amick Brown is an Information Technology consulting company specializing in ERP, Data Analytics, Information Security, Application Development, Networking, and Cloud Computing. The company was founded in 2010 and is headquartered in San Ramon, California.