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.
Responsible for coordinating and performing review and approval of completed batch records, raw material records, validations, stability records, and other quality documents to ensure compliance with applicable procedures, test specifications, and methods.
Performs document record review and approval (DRR) of batch records, equipment qualifications, calibration records, analytical methods, method validations, stability protocols, and other quality documents for completeness and accuracy.
Responsible for generating and reviewing Certificates of Analysis for catalog and custom projects.
Assist in preparation and hosting external audits including customer, ISO and DEA audits.
Generate quarterly reports summarizing documentation review and documentation errors.
Perform review and approval of Standard Operating Procedures to ensure compliance with regulatory and company quality requirements.
Conduct internal and external audits as needed to maintain an audit schedule.
Ability to use standard office computers daily and to use a telephone for communication.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- While performing the duties of this job, the employee is occasionally exposed to work near moving mechanical parts; fumes or airborne particles; toxic or caustic chemicals; risk of electrical shock and vibration. The noise level in the work environment is usually moderate.
- The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell.
- The employee must occasionally lift and/or move up to 25 pounds.
- Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.
- The employee must have the ability to perform moderately physical activity
- This is a Laboratory setting and production environment: Required to wear all required personal protective equipment (PPE). May be required to work with chemicals such as flammable solvents and corrosives.
Who You Are:
- Bachelor’s degree in life science discipline
- 1+ years of experience working with ISO guidelines and regulations
- Experience in an ISO and/or GMP regulated manufacturing environment
- Strong technical knowledge base and the ability to comprehend and communicate basic technical concepts
- Proficient computer skills specifically MS Office (Word, Excel, PowerPoint, Access)
- Excellent communication skills. The ability to respond to colleagues effectively; both verbally and in writing. The ability to interact and work well with other team members. The employee must be able to approach others to discuss work-related items in a manner that will allow for a successful outcome
- Efficient and effective time management, planning and scheduling skills
- Problem-solving skills including root cause analysis
- Self-motivated and able to work independently
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.