Blue Stream Laboratories, a fast-growing biochemical/analytical CRO, seeks a creative, highly-motivated individual who is ready for an exciting, entrepreneurial workplace, and who wants to contribute to a dynamic, success-driven team.
The candidate will oversee the Quality Assurance function and will have responsibility for developing, implementing, and supervising all QA programs and activities at Blue Stream.
Responsibilities will include further developing and maintaining all internal cGMP policies and procedures, and assuring comprehensive compliance with those policies and procedures. Specifically, the responsibilities will include, but are not limited to, the following:
- Advancing, evolving, and improving all laboratory quality systems
- Ensuring compliance of operational staff to cGMP regulations
- Maintaining all quality documentation and document tracking systems
- Conducting and coordinating internal and external audits/inspections
- Communicating/interacting with clients, regulatory authorities, auditors, etc.
- Reviewing/approving cGMP protocols and reports including those in support of lot-release programs, stability, qualification, and ICH validation activities
- Investigating, documenting, and tracking cGMP deviations, change controls, OOS, CAPAs, etc.
- Providing guidance and training to employees to ensure compliance to cGMP's and SOP's
Basic Qualifications:
Bachelor's degree in chemistry/biochemistry or in a life science plus 5-10 years quality assurance leadership experience in biotech or pharmaceutical industries. In-depth experience in FDA and EMEA compliance/quality issues.
Strong leadership skills as well as good management, communication, writing and presentation skills, computer skills, energy and professionalism are also critically important.
To apply for this position, please email your resume to: recruiter@bluestreamlabs.com. Please specify Job Code WSQA110
