Aerotek Scientific is actively recruiting for a biopharmaceutical company in Boulder, CO. This role will assist in the successful delivery of the GMP Quality Assurance and Compliance objectives through effective oversight, and implementation of quality initiatives.
The purpose of this assignment is to perform clinical and commercial batch record review and product approval. Will track document receipts from contractors, revising existing and implementing new standard operating procedures and templates, continuous improvement of quality systems and processes, and archival of documents.
- Review and approve contractor manufacturing, packaging, and analytical records to ensure completeness and consistency with company policies and procedures necessary for batch release of clinical and commercial intermediates, API and drug products.
- Review and approve labeling and packaging specifications, master records, and change control.
- Review contractor investigations, deviations, complaints and initiate necessary records according to company procedures.
- Report quality metrics to QA Management for review
- Maintains databases and systems used for tracking various GMP manufacturing associated support activities
- Generation and/or revision of GMP documentation such as standard operating procedures
- Works closely with Regulatory, Supply Chain and Manufacturing, and contractors to prioritize documentation review and product release.
- Continually evaluate systems and procedures for improvement while ensuring compliance to applicable regulatory requirements and standards
- Maintain documentation and records to ensure GMP Quality standards and compliance.
- Support Regulatory Authority inspections and internal & external audits
- BA/BS with Biology/Chemistry focus or equivalent industry experience.
- 3-5 years of experience in a regulated or GxP environment.
- Experience in a virtual Quality role in a GMP environment for small molecule drug substances and dosage forms (oral and parenteral) preferred.
- Strong organizational skills, ability to multitask in a dynamic, fast paced environment.
- Demonstrated analytical and logic skills with a focus on fact-based decision making and problem-solving.
- Strong collaboration and written /verbal communications skills.
- Experience with MasterControl preferred.
Please apply with two professional references and updated resume.
Our people are everything. As a Best of Staffing® Client and Talent leader, Aerotek® Inc. has distinguished itself as a leader in recruiting and staffing services, by having a deep understanding of the intersection of talent and business. As a strategic partner to more than 17,000 clients and 300,000 contract employees every year, Aerotek's people-focused approach yields competitive advantages for its clients and rewarding careers for its contract employees. Headquartered in Hanover, Md., Aerotek operates a network of over 230 non-franchised offices with more than 6,000 internal employees dedicated to serving our customers. Aerotek is an operating company of Allegis Group, a global talent solutions provider. To learn more, visit aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.