What are the responsibilities and job description for the Quality Control Analyst III (Day Shift - Day shift 7am -3:30 pm or 8 position at Teva Pharmaceuticals?
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Quality Control Analyst III (Day Shift - Day shift 7am -3:30 pm or 8-4:30pm)
Date: Jan 30, 2025
Location:
Fairfield, United States, 45213
Company: Teva Pharmaceuticals
Job Id: 60503
Who we are
Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.
How you’ll spend your day
Essential Job Responsibilities
- Provide Analytical technical service support to QC
- SME TrackWise change controls for specifications/method revisions in wisdom/LIMS
- SME Wisdom Teva doc for revising, creating, reviewing and making effective specifications and method documents.
- SME LabWare LIMS PROD_SPEC role for creating and revising specifications in LIMS and resolve LIMS specification issues
- Support alternate supplier project and perform method transfer for required methods such as Impurity and residual solvent
- Additional responsibility for Compendial Compliance to track USP/NF update for monograph, general chapters etc., track assessment in compendia review TW change controls, Initiate change control if any specification/method revision required
- Additional responsibility for packaging engineering specifications for Labels, Outserts, Shippers, Bottles, Closures which need creation or revision due to either regulatory change or supplier change notification.
- Method remediation, validation studies testing, initiate protocols, set up HPLC, process and report data and draft reports.
- Revise packaging component printed labels/outserts specification in Wisdom/LIMS
- Creating protocols to perform USP verification testing and issuing verification reports prior to USP monograph becoming effective
- Revise residual solvent reports based on USP or supplier notifications
- Creating TrackWise CAPA’s for method/specification assessment, corporate standard gap analysis related to method transfer/ method validation
- Support QC chromatography tests and chromatography data review and additional QC projects as per business need
- Assigned project such as corporate standard gap assessment, SOP revision, CAPA, Lab Investigations etc.
- Train QC Analysts when required
Required:
- Good computer skills including MS Office, protocol/report writing
- Working knowledge and experience using Labware LIMS documentation system, Trackwise for change controls, laboratory investigations and CAPA
- Knowledge of method validation/ method transfer
- Working knowledge of USP/PF updates, tracking changes, implement and update method/specification
- Working knowledge of HPLC, GC and other spectroscopic methods (UV/Vis spectrophotometer, FTIR, Raman spectroscopy), dissolution and other stand-alone systems
- Strong analytical skill to troubleshoot HPLC/GC instruments and Empower data acquisition system
- Knowledge to perform method transfer/remediation projects, analysis of raw material and finished dosage pharmaceutical products
- Good at multitasking, handling multiple projects at one time, and changing priorities based on business needs
- Working knowledge of USP, and cGMP, requirements in a pharmaceutical quality control laboratory
- Must be detail oriented, self-driven, and motivated
- Good organization skills and attention to detail
- Strong interpersonal, oral, and written communication skills
- Able to work effectively independently and as part of a team
- Knowledge of ERP system SAP
- Knowledge on Laboratory safety procedures
Your experience and qualifications
Education Requirements:
- Bachelor’s/master’s degree in chemistry or related science
- Minimum ten (10) years of Analytical laboratory experience
Physical Requirements:
- Not allergic to chemicals or bio substances found in laboratory or production facilities.
- Not Allergic to Penicillin/Cephalosporin drug products
- May be required to lift/move up to 50lbs.
- Individual may be required to handle hazardous and non-hazardous materials.
- Individual may be required at times to wear Personal Protection Equipment.
- May be required to lift/move up to 50lbs.
- Individual may be required to handle hazardous and non-hazardous materials. Individual may be required at times to wear Personal Protection Equipment.
- Not allergic to chemicals or bio substances found in laboratory or production facilities.
Enjoy a more rewarding choice
We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.
Already Working @TEVA?
If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site
The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.
Teva’s Equal Employment Opportunity Commitment
Teva’s Equal Employment Opportunity Commitment
Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
Please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience. Request a reasonable accommodation by sending an email to disabilityassistance@tevapharm.com with the nature of your request and your contact information. Only inquiries concerning a request for a reasonable accommodation will be responded to from this email address.
Important notice to Employment Agencies - Please Read Carefully
Teva Pharmaceuticals USA does not accept unsolicited assistance from agencies for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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