Overview
Remote
On-site
Job Description
- Review of event documentation such as Batch records, Exceptions, and Regulatory filings
- Production record review and Product disposition for drug substance, drug product, device assembly and finished goods
- Support design development plan including design verification and DHF deliverables
- Build and maintain Product Specification Files (PSF) for Alnylam program
- Knowledge of relevant government regulations and agency rules for labeling (CFR & EudraLex Volume 4, Annex 13)
- Understanding of ICH, GLP, CGMP requirements, GXP regulations and current industry practices.
- Demonstrated teamwork, initiative, and problem-solving skills
- Ability to prioritize and work independently with minimal supervision
- Ability to accurately determine deadlines and ask for help if needed
- Detail oriented with solid problem-solving acumen.
- Ability to work effectively in a team environment with great organization skills.
- Ability to independently analyze and reconcile moderate to complex issues.
- Must have demonstrated initiative and accountability in a fast-paced environment.
- Excellent verbal and written communication and interpersonal skills.
- Proficient with computers and word processing software (i.E., Microsoft Office products)
- Minimum, a BS degree in life sciences, engineering or related field
- Minimum of 5 years pharmaceutical quality assurance experience in a GMP manufacturing and supply chain environment
- Good understanding of FDA and EMA regulations and guidelines
- Excellent organizational, communication, and interpersonal skills.
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FAQs About Tech Ops & Quality - QA Sr. Specialist GMP Jobs at Lancesoft
What is the work location for this position at Lancesoft?
This job at Lancesoft is located in Cambridge, MA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Lancesoft?
Candidates can expect a pay range of $65.
What employment applies to this position at Lancesoft?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Lancesoft?
You can apply for this role at Lancesoft either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.