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* Review all QC/QA related documents in support of the process validation campaign, finished drug products, drug substances, and stability samples, including specifications, method validation and stability protocols and reports
* Coordinate and Trend data generated at external CMOs/CROs
* Ensure all QC/QA activities are in accordance with regulatory and industry guidances
* Communicate any discrepancies, issues, or questions to the external testing site, Analytical project leads, and management
* Demonstrate effective leadership and ensure close collaboration with external testing sites, Analytical project leads, and management
* Ensure that all testing is completed and recorded according to Good Documentation Practices and relevant SOPs
* Write, review, and approve Change Controls, CAPA's, QC deviation reports, and participate in out of specification (OOS) and out of trend (OOT) investigations where required
* BS/MS in a science or technical field with a minimum of 7 years' working in a Quality Control pharmaceutical industry - relevant cGMP experience
* Strong technical knowledge of analytical chemistry including advanced knowledge of method transfer/validation, chromatography, and all pharmaceutical development analytical laboratory techniques
* Effective written and oral communication skills at individual, team, and organizational levels
* Experience working on cross-functional teams and managing relationships in collaborative, constructive manner with internal departments and international vendors and partners
* Extensive knowledge of cGMP, 21 CFR 211 and 21 CFR Part 11, specifically, ICH Q7, Q1 (A, B, C, D, E and F) Q2, Q3 (A, Band C) and USP, EP and JP test requirements
* Detailed knowledge of Quality management systems
* Ability to navigate and be successful in a fast-paced, matrixed, deadline oriented work environment
* Ability to handle multiple priorities to meet project team goals and timelines
* Experience using Microsoft Office-Word, Excel, Outlook
* Ability to work 40 hours per week during normal business hours (EST time)
* Experience with analytical development, regulatory affairs and quality assurance is a plus
* Experience with Veeva a plus
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
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Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, a commitment to project completion and success and a passion for innovation, creativity and continuous improvement.
Our niche brands provide direct hire, executive search, temporary staffing, contract consulting and temp/contract-to-hire solutions to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
Learn more about Beacon Hill Staffing Group and our specialty divisions, Beacon Hill Associates, Beacon Hill Financial, Beacon Hill HR, Beacon Hill Legal, Beacon Hill Pharma and Beacon Hill Technologies by visiting www.beaconhillstaffing.com.
We look forward to working with you!
Beacon Hill. Employing the Future™
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