Quality Assurance Associate
Full-time
Krystal Biotech
About Krystal Bio: At Krystal Biotech, we bring together the brightest and most eager minds to relentlessly pursue the discovery, development, manufacturing, and commercialization of genetic medicines to treat diseases with high unmet medical needs. Founded in 2016, Krystal is distinguished in three powerful ways: science and technology using our patented gene therapy platform, innovative manufacturing supported by our commercial scale facilities, and a unique commercialization model that focuses on the patient’s end-to-end experience. Krystal received U.S. FDA approval for the first and only redosable gene therapy treatment, VYJUVEK®, for the treatment of Dystrophic Epidermolysis Bullosa (DEB). Krystal continues to leverage our proprietary platform to rapidly advance a robust pipeline of investigational genetic medicines in respiratory, oncology, dermatology, and ophthalmology. Krystal is headquartered in Pittsburgh, PA, which is home to our two state-of-the-art CGMP manufacturing facilities with teams around the world and satellite offices in Switzerland, Germany, and Japan. We are a company built and run by people who care, are fearless in the face of a challenge, love the work they do, and practice the highest level of scientific integrity. As we grow, we are seeking team members that embody these values. Job Description Summary: Krystal Biotech, Inc. is seeking a highly motivated and experienced Quality Associate to support quality systems, GMP manufacturing processes and documentation practices at our headquarters in Pittsburgh's South Side. Primary Responsibilities:
- Work with internal teams to obtain an understanding of the product and the documentation requirements.
- Produce high-quality documentation that meets applicable standards and is appropriate for its intended use.
- Develop expertise on FDA regulations and audit processes.
- Initiate and update GMP manufacturing associated documentation, such as clearing procedures.
- Provide oversight of daily QA functions which include review and approval of records generated by manufacturing and quality control documents.
- Provide support for updates on standard operating procedures and associated forms.
- Assist with QA efforts for site cGXP documentation related to the operation of gene therapy manufacturing.
- Ensure compliance with regulatory agencies and oversee continuous improvement of company's QA and compliance functions.
- Minimum of a Bachelor’s Degree (Biology or related Life Science) with 3+ years of relevant quality systems experience in the biotech or pharmaceutical industry.
- Background that includes knowledge/experience in GMP, GLP, and GCP.
- Experience with FDA audits is highly preferred.
- Strong knowledge of GMP and ICH requirements.
- Must be a self-starter and capable of working with minimal oversight.
- Must be able to handle multiple roles and work in a fast paced and changing environment and know how to prioritize activities appropriately.
- Excellent oral and written communication skills.
Vacancy posted a month ago
Similar jobs that could be interesting for youBased on the Quality Assurance Associate in Pittsburgh, PA vacancy
- ...define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply. The Quality Assurance Associate I performs detailed quality reviews of batch records and associated records for final dispositioning and ensuring...SuggestedWork at officeWeekend workAfternoon shift
Cook Medical
Pittsburgh, PA4 days ago - ...Job Description Job Description Tittle: Quality Assurance Associate Location : PA – Pittsburgh Mode : 5 days on site Duration : Contract to Hire Years Of Exp Required : 3+ Years Function of the Group: Testing for Teller Applications / Manual testing of Teller...SuggestedContract work
System One
Pittsburgh, PA29 days ago - ...Job Title We are seeking a dedicated individual to join our team to test the teller application, ensuring it meets the highest quality standards. Location 500 First Ave., Pittsburgh, PA, 15219 - 5 days onsite Salary Range Not specified Required Skills...Suggested
Artech
Pittsburgh, PA1 day ago - ...manufacturer of chemical fluid handling components and systems, we deliver innovative, industry-specific solutions that raise efficiency, quality, and safety worldwide. What You'll Do (In Short) Commission and verify ProMinent skids: hydro/pressure test, calibrate pumps,...SuggestedFull timeTemporary workWorldwide
ProMinent Fluid Controls - USA
Pittsburgh, PA4 days ago - ...Reviews legislative and program proposals/changes to determine impact on the call site/campus/Taxpayer Assistance Center (TAC) and the quality of service to the taxpayer. # Evaluates current procedures and policy, proposes appropriate action, which may include providing...Suggested
Internal Revenue Service
Pittsburgh, PA4 days ago - ...Description: The Quality Auditor is responsible for completing inspections related to evaluations, certifications, or listings, including... ...in building construction, manufacturing, or performing quality assurance audits preferred. Demonstrated exceptional written and oral...Work at officeRemote work
International Code Council
Pittsburgh, PA5 days ago - Taxpayer Services A description of the business units can be found at: Position(s) are to be filled in following area(s): TS - Non Service Center Limited Area Of Consideration: This job is open to current permanent IRS competitive service employees in Taxpayer...Permanent employment
US Government Jobs
Pittsburgh, PA1 day ago - ...has resisted innovation. Join us!Position Overview:The Pharmacy Quality Improvement Specialist plays a critical role in overseeing... ...reporting process. This role requires a proactive approach to quality assurance, including reviewing patient feedback and other critical...Work at officeRotating shift
$76.44k
...: • Develop, implement, and maintain the project-specific Quality Assurance Surveillance Plan (QASP) in compliance with Federal Acquisition... ...including, but not limited to, the role, function and associated responsibilities, relevant work experience, skills, required...Contract workFor contractorsWork experience placementFor subcontractorH1bImmediate startFlexible hoursCDM Smith
Pittsburgh, PA1 day ago- ...floor. In this role, you will primarily evaluate and price donated clothing and accessories, using your knowledge of brands, fabric quality, condition, and resale demand. You will accurately assess the value of donated items based on condition, quality, brand recognition...Local area
$75k - $137.5k
...contribute to the company’s success. As a Quality Engineer Specialist within PNC's... ...and effectively managing all of the risks associated with their business objectives and activities... ...Testing, Corporate Governance, Quality Assurance (QA), Quality Support, Software Testing,...Full timeTemporary workPart timeWork experience placementWork at office
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Quality Assurance Associate. Be the first to apply!
Related searches
- quality lead Pittsburgh, PA
- quality management nurse Pittsburgh, PA
- supplier quality Pittsburgh, PA
- quality improvement rn Pittsburgh, PA
- rn quality Pittsburgh, PA
- quality assurance quality control engineer Pittsburgh, PA
- quality distribution Pittsburgh, PA
- quality tech Pittsburgh, PA
- aerospace quality Pittsburgh, PA
- water quality Pittsburgh, PA