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Data Integrity Compliance Officer
A career with MilliporeSigma is an ongoing journey of discovery: our 57,000 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.
Quality Control in St. Louis, MO, supports manufacturing of custom products including active pharmaceutical ingredients, excipients, and raw materials used within the health care industry.
The Data Integrity Compliance Officer position will be a part of the Quality department. This position will report into a manager role. This position will currently have no direct reports. This role will receive moderate to low level guidance and direction.
The Data Integrity Compliance Officer will be responsible for ensuring that all QC laboratories are in compliance with industry regulations, corporate data integrity standards, documentation practices and procedures as related to both paper and electronic records.
The Data Integrity Compliance Officer will be a leader that ensures quality data reporting for the Quality Control department (QC teams are as follows: Analytical Release, ADC Release, Raw Material Release, Data Systems, Quality Control review, Micro, Environmental Monitoring, Stability, Analytical Validation). This position will also interact with other cross functional Cherokee teams on a needed basis (Ex. QA, Process and Analytical Development PAD, Manufacturing, Site Validation, and Information Technology).
- Ensures data integrity practices and procedures are implemented and adhered to for quality compliance and to meet industry standards. Establishes operational objectives and assists with developing, modifying and executing company policies.
- Ensures all new and existing equipment is assessed appropriately and validated for its intended use and existence.
- Independently evaluates new instrumentation and software from a data integrity standpoint, identifying any potential gaps in the system prior to purchasing.
- Provides gap assessments and status updates to senior management to maintain and improve data integrity
- Performs risk assessments to determine high risk equipment and determines appropriate corrective action.
- Leads departmental data integrity training for all lab personnel, ensuring awareness and compliance with data integrity for both paper and electronic records. Ensures appropriate inspector interactions and good documentation practices.
- Develops, manages, and updates procedures as necessary to ensure there is clear direction and understanding regarding awareness, responsibilities and the importance of corporate and regulatory requirements for data integrity compliance.
- Creates and executes change controls and establishes user requirements for laboratory and operations equipment.
- Ensures all software used for the generation of current Good Manufacturing Practices (cGMP) meets the standards required for data integrity compliance.
- Detects and independently investigates complex data integrity concerns and documents any data integrity compliance issues by conducting employee interviews and in-depth investigations and appropriate corrective actions.
- Represent QC for data integrity matters during regulatory agency and customer inspections
Who You Are:
- Bachelor’s degree in chemistry, biochemistry, biology, or another life science discipline
- 5+ years of any combination of experience within QC instrumentation, Analytical Validation, Computer System Validation, Data Acquisition Software Systems (Ex.Chromeleon) and/or Manufacturing process equipment.
- 3+ years of experience reviewing documents related to standard operating procedures, data, audit trails, protocols and/or instrument qualifications.
- Master’s degree preferred
- Other general laboratory instrumentation experience with: HPLC, GC, LC-MS, CGE, iCE, IC, KF, Particle Size, AA, TOC, ELISA highly preferred
- 5+ years of GMP experience in pharmaceutical, biopharmaceutical or similar industry desired
- Technical knowledge related to data integrity to quality control data from chromatographic systems is desired. Experience with laboratory metrology and instrumentation compliance. Equivalent combinations of education, training, and relevant work experience may be considered
- Strong computer skills, including word processing, and Quality systems databases.
- Knowledge of basic laboratory techniques.
- Knowledge of FDA practices and guidelines.
- Knowledge of pharma/biotech bulk and finished product manufacturing and analytical testing requirements.
- Knowledge of analytical instrumentation and software, and medical devices.
- Knowledge of ICH Q7A, 21CFR and Eudralex GMP regulations
- Strong technical writing, root cause analysis and scientific reasoning
- Chemical environment-Must be able to perform tasks while wearing personal protective equipment
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.