We are seeking a dedicated professional to draft, review, and finalize Quality Agreements and Change Notifications with customers across multiple sites within BCD and the broader BPG group. This role also involves cross-functional partnership to support, develop, and implement Divisional Quality Management System (QMS) policies and procedures, ensuring their adequacy and compliance with internal, customer, and regulatory standards.
Key Objectives of the Role:
The key responsibilities of this role will include, draft, review, and finalize Quality Agreements and Change Notifications with customers for multiple BCD sites and the wider BPG group. Actively support and handle change management and notification activities relating to BCD business processes as well as supporting BCD document management with multi-functional team members and sites.
Address complex quality issues directly with customers and support issue resolution.
Collaborate across functions to support development and implementation of Divisional QMS policies and procedures. Assist in the creation and modification of processes and procedures to ensure their efficiency.
Participate in multi-functional projects of moderate scope to support the BCD Quality Management System.
Drive continuous improvement initiatives to ensure the effective implementation of the QMS.
Ensure the BCD Quality Management System maintains consistent product quality and regulatory compliance.
Knowledge and Skills:
Strong proven understanding of compliance with quality standards (e.g., EU GMP, 21 CFR Part 210, 211, 820, ISO 13485, 9001, MDSAP).
Proficient in Computer applications and software (Microsoft Excel, Outlook, Word, Access, Project); compliance specific software programs (Agile, Trackwise, LIMS, Master Control, ERP, etc.).
Familiarity and proficiency with global systems such as Trackwise, ORACLE, and E1/SAP.
Minimum Qualifications:
Bachelor's degree in a Science field with 1-3 years of experience in a quality function within a regulated environment, or a Bachelor's degree in a non-scientific field with 3-5 years of relevant quality experience in the Medical Device or Pharmaceutical industry.
Familiarity with quality standards (e.g., 21 CFR Part 820, ISO 13485 ISO 9001).
Experience with US Pharmacopoeia, European Pharmacopoeia, Japanese Pharmacopoeia, and British Pharmacopoeia testing would be of benefit.
Working Conditions:
Works in an office environment. May be required to work overtime to complete tasks if required.
We offer competitive salary, an annual incentive bonus plan, 401K with company match up to 6%, tuition reimbursement and a range of other employee benefits! We foster an exciting company culture that encourages innovation, forward-thinking, and an outstanding career and development prospects.
Compensation and Benefits
The salary range estimated for this position based in New York is $60,000.00-$90,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
