Quality Control Specialist (Drug Product)

Rensselaer, NY, United States
Nov 25, 2020
Required Education
Bachelors Degree
Position Type
Full time

Executes the drug product fill and finish projects with responsibilities in components test method development and validation, and design verification and validation. Develop analytical methods for the assembly process development for clinical and commercial combination products.

Essential Duties and Responsibilities may include, but are not limited to, the following:
• Process development for the assembly and packaging of clinical and commercial combination products, including vials, prefilled syringes, safety system, auto-injector, and novel delivery systems
• Executes combination product development projects on time, in scope, and within budget with responsibilities of identifying new device and drug product test methods in support of product characterization and design verification.
• Generates documentation needed to support characterization, method development, method validation, and device design verification testing activities
• Documents deviations, performs investigations, and implements corrective/preventive actions as required.
• Works closely with cross-functional team, including Combination Product Development subject matter experts, Quality and others to assure project success
• Facilitates transfer of newly developed physical test methods to internal and external QC functions as needed to support design transfer activities.
• Leads cross functional meetings and facilitates communication between assembly site and Combination Product Development engineers to ensure requirements from development are being translated into manufacturing
• Ensures that products to be assembled are technically robust (e.g. through engineering analysis), ensuring that combination products after assembly perform sufficiently and reliably
• Identifies areas of project risk, escalates issues and risks in an expedient manner, and actively proposes solutions
• Assures work activities are conducted in a manner compliant with all applicable regulations and industry standards
• Maintains a culture of continuous improvement that strives to ensure product safety and efficacy while accelerating delivery of commitments

Knowledge, Skills & Abilities:
• Ability to maintain integrity and honesty at all times
• Ability to work independently or as part of a team
• Ability to communicate with transparency
• Continuously drive to improve processes for improved performance
• Accountable for technical performance and results of team
• Manage internal and external relationships
• Develop strategy and create metrics to measure effectiveness of strategy
• Translate ambiguity and translate into actionable steps
• May manage others through influence rather than direct authority
• Ability to resolve conflicts and coach others on problem solving
• Handle issues appropriately and with a sense of urgency

Education and Experience:
• Requires BS/BA with 3+ years of related experience in a cGMP environment. MS degree preferred.
• Experience writing technical documents such as test reports, technical memos, test protocols, input requirements documents is required.
• Experience in the medical device industry is preferred.
• Experience in the development of regulated medical devices or combination products under Design Control (21 CFR 820) and ISO 14971 is preferred.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.