Show All Results
Analytical Method Validation Scientist, QC
A career with MilliporeSigma is an ongoing journey of discovery: our 56,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others. MilliporeSigma is a business of Merck KGaA, Darmstadt, Germany.
The main function of this role will include validation and qualification of analytical testing methods working with development teams/project teams and customers. The Scientist, Quality, Sr position is responsible for the analysis of samples in the Quality Control department and all related paperwork. Analysis involves the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments. The position demonstrates the ability to work on, and solve, problems independently with little guidance. This position is responsible for performing method qualification and validations, as well as for developing analytical methods to support validations, and for maintaining project timing/costs by interacting with internal/external clients to assure project goals are met. This position is responsible for writing protocols and standard operating procedures and training other staff on laboratory techniques. Reviewing/evaluating analytical data for final products, intermediates, and raw materials may be required to support review, root cause investigation, and technical writing. Other responsibilities include participation in process improvement initiatives, maintaining a clean and safe working environment, and supporting the department in maintaining the laboratory in an audit ready state. The Scientist, Quality, Sr position, like all positions at SAFC, will require a willingness to contribute to the overall success of the company by assisting in many areas beyond specific job duties.
- Work on complex and challenging problems in which analysis of data requires an in-depth evaluation of various factors. Apply theoretical concepts and good scientific rationale to identify root cause analysis and implement corrective and preventive actions.
- Exercises independent judgment in developing methods, techniques, and evaluation criteria for obtaining results.
- Acts independently to determine methods and procedures on new assignments and may provide guidance and oversee new and less experienced personnel.
- Able to recognize problems before they happen.
- Able to solve problems and make decisions independently.
- Assumes a leadership role within the department.
- Demonstrates an understanding of FDA/ICH/USP guidelines.
- Able to interpret analytical data (including FT-IR, 1H NMR, MS).
- Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program. Understands ICH guidelines and their application to assigning shelf life.
- Develop testing methods to support cleaning verification program; validate or verify methods as necessary.
- Perform cleaning verification by executing existing methods.
- Perform review of analytical data for accuracy and quality.
- Train new and less experienced personnel in SOP content, analytical techniques, and instrument use.
- Meet with internal and external project groups to keep projects on track.
- Maintain projects and timelines without oversight while keeping management informed.
- Execute method transfers into QC and write summary reports.
- Perform method validations and write technical reports.
- Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair.
- Analytically test in-process, final products, intermediates, and raw materials. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
- Support OOS investigations via testing and good documentation; has ability to lead investigations with minimal guidance from management.
- Perform requalification of reference standards and maintain reference standard inventory/documentation.
- Write and revise SOPs including raw material, intermediate, and final product specifications.
- Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
- Demonstrate proper laboratory techniques.
- Work cooperatively within the QC department and with other departments to achieve project goals. Communicate with project management and provide technical updates.
- Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
- Work in a safe manner and maintain the cleanliness of the work environment.
- Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.
- Regularly required to sit, stand, walk, reach above the shoulder, stoop, kneel, twist, crouch, or crawl for extended periods of time.
- Must occasionally lift and/or move up to 25 pounds unassisted and be capable of pushing and pulling heavy materials to complete assignments. May be required to lift more poundage with assistance.
- Must be able to speak, hear, taste, and smell.
- Specific vision requirements include close vision, distance vision, color vision, peripheral vision, depth vision, and the ability to adjust focus.
- Regularly use phones, computers, computer monitors, and all office/laboratory equipment.
- Required to type at a computer keyboard and can read CRTs/computer monitors.
- Environmental conditions: Work near moving mechanical parts. Frequently required to wear appropriate protective gear (hard hats, lab coats, safety glasses/goggles, chemical resistant sleeves, gloves, safety shoes) and other personal protective equipment “PPE” to protect from toxic or corrosive chemicals in the forms of liquids, solids, vapors, or airborne particles.
- Must be willing to work with highly potent/hazardous materials requiring the use of proper PPE, which could include half/full face respirators.
Who You Are:
- B.S. in Chemistry or another biological sciences discipline
- 5+ years of experience in a GLP or cGMP analytical laboratory environment
- 3+ years analytical methods validation experience
- Master’s degree preferred
- 12+ years related work experience in a GLP or cGMP analytical laboratory environment.
- Excellent written and verbal communication skills, technical writing skills, as well as excellent documentation practices.
- Ability to lead or work within a team environment and in analytical testing labs with hazardous and toxic chemicals.
- Advanced knowledge and understanding of organic analytical chemistry, method validation, qualifications and technical transfers
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.