BostonRecruiter Since 2001
the smart solution for Boston jobs

QC Analyst II

Company: Yoh, A Day & Zimmermann Company
Location: Winthrop
Posted on: April 10, 2021

Job Description:

The Quality Control Analyst II will work within the Quality Control Technical Service (QCTS) group, managing and maintaining the documents and quality records for late stage and commercial product specifications of Client's therapeutic programs for the management of product-lifecycles. Additionally, this role supports the CMC program teams by providing documents for a timely release of material, upcoming manufacturing campaigns, maintenance of the stability program, regulatory needs, compliance of commercial materials, and initiation of clinical trials. A person, who is self-driven, can multi-task, has open and amiable communication style, and strongly believes in the Client'score values of Commitment to People, Passion for Excellence, Open Culture, Sense of Urgency, and Innovation and Discovery, would be successful in this role. Summary of Key Responsibilities

  • Manages late stage and commercial documents for the release and stability testing of Clientdrug programs as they advance) for internal and regional use.
  • Responsible (authoring, initiation, and review) for quality records (change controls, CAPAs, deviations, SOPs, risk assessments, etc.), specifications, and justification of specification reports. Responsible for coordinating QC impact assessments as part of quality records.
  • Maintains ad hoc meetings with the Specification Review Board, a cross-functional team, to support the lifecycle of early (in partnership with Analytical Sciences), late, and commercial programs.
  • Supports multiple CMC program teams by providing documents in a timely manner for: product and product release, stability programs, extension of shelf life for products, and commercial launch.
  • The role requires regular interactions with senior members of cross functional teams and provides project management and Subject Matter Expert (SME) knowledge for product specifications (API, drug product, intermediates, and potentially critical starting materials) to support CMC teams.
  • Coordinates with Quality and Program Managers to provide project updates, workflows, and timelines. Maintains the QC department dashboard to show the current status of programs/deliverables.
  • Perform data verifications (data integrity review), support analytical method validations, and perform statistical analysis of data, as needed. Requirements
    • B.S. in chemistry or a related discipline
    • 3+ years of experience in an industrial setting, preferably in a cGMP environment as it pertains to the biopharmaceutical industry
    • Understanding and working knowledge of statistical analysis of data, lifecycle management of late-stage and commercial products, and commitment to data integrity. The successful candidate would have a good command of technical writing in English.
    • Prior experience with relevant ANVISA, EMA, FDA, ICH, and JP guidelines as it pertains to drug substance and drug product specifications
    • Knowledge of regulatory processes in relation to filings and marketing applications for Module 3 (amendments, CTD, IMPD, IND, NDA, MAA, etc.)
    • Expertise in OOS/OOT/Atypical resolution, deviations, change controls, root cause analysis, and monitoring CAPA effectiveness would be a desirable.
    • Strong collaborative, communication, and time management skills
    • Sound judgement and commitment to transparency and integrity Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Visit to contact us if you are an individual with a disability and require accommodation in the application process.PandoLogic. Keywords: Quality Control/Quality Assurance Analyst, Location: Winthrop, MA - 02152

Keywords: Yoh, A Day & Zimmermann Company, Boston , QC Analyst II, Professions , Winthrop, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Professions Jobs


CDL A Truck Driver
Description: Hiring CDL drivers in your area. Apply once and choose a trucking job that works for you. Get home when you want to, and get paid what you deserve br Available Trucking Jobs: br
Company: Live Trucking
Location: East Providence
Posted on: 04/17/2021

CDL-A Truck Driver (East Providence,RI)
Description: WESTERN EXPRESS NEEDS CDL-A DRIVERS CALL TO TALK TO A RECRUITER TODAY 888- - Western Express is now hiring company truck drivers, trainees, and driver trainers. Whether you're an experienced driver (more...)
Company: Western Express
Location: East Providence
Posted on: 04/17/2021

CDL-A Flatbed Driving - Flatbed Training Available
Description: HIRING COMPANY FLATBED DRIVERS br br REGIONAL AND OTR POSITIONS AVAILABLE br br EARN MORE IN YOUR FIRST 6 MONTHS WITH US, OR WE'LL GIVE YOU 3,500 br br COTC was built by flatbed drivers (more...)
Company: Central Oregon Truck Company
Location: East Providence
Posted on: 04/17/2021


CDL-A Company Driver - OTR Dry Van - Graduated Training (Concord,NH)
Description: Hiring: CDL-A Drivers for OTR Company Driving Positions. 5000 Sign on Bonus
Company: Big M Diesel Express
Location: Concord
Posted on: 04/17/2021

CDL A Regional Truck Driver
Description: Join the Cowan Family as a regional road driver out of Londonderry, NH hauling Dedicated Freight. You'll enjoy our newly increased pay packages with a variety of schedules and shifts to fit your lifestyle. (more...)
Company: Cowan Systems
Location: Concord
Posted on: 04/17/2021

94E Radio and Communications Security Repairer
Description: AGE REQUIREMENTS: Must be between the ages of 17 and 35 br br It's extremely important that Army National Guard communications don't fall into the wrong hands. As the Radio and Communications Security (more...)
Company: Army National Guard
Location: East Providence
Posted on: 04/17/2021

CDL-A Company Driver
Description: Hiring CDL drivers in your area. Apply once and choose a trucking job that works for you. Get home when you want to, and get paid what you deserve br Available Trucking Jobs: br
Company: Live Trucking
Location: Concord
Posted on: 04/17/2021

Cure Room Technician
Description: Location: 5 Forge Parkway Franklin MA 02038 br Everyone is welcome here. Each of us is unique, and that's what makes us amazing. We believe in inclusiveness and celebrating each person's individuality, (more...)
Company: Neta
Location: East Providence
Posted on: 04/17/2021

1452-Inventory Control and Assurance Specialist (Franklin Distribution)
Description: Location: 5 Forge Pkwy, Franklin, MA br Everyone is welcome here. Each of us is unique, and that's what makes us amazing. We believe in inclusiveness and celebrating each person's individuality because (more...)
Company: Neta
Location: East Providence
Posted on: 04/17/2021

CDL-A Truck Driver - No Experience Required!
Description: CDL-A STUDENT TRUCK DRIVER JOBS br br COVID-19 RESPONSE br br Recent CDL-A Graduate No Experience Required br br New CDL-A truck driver school
Company: J&R Schugel
Location: East Providence
Posted on: 04/17/2021

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds