Change Control Specialist

BioSpace; City of Rensselaer (NY); On-site; USD 59,700 - 126,800; Full time

Benefits offered by this job

Health and wellness programs

Fitness centers

Equity awards

Annual bonuses

Paid time off

Job summary

A leading biotech firm is seeking a Change Control Specialist to advance change control initiatives and implement corrective actions. The ideal candidate will have a Bachelor's degree in Life Sciences or Engineering, with relevant experience based on the role level. Responsibilities include crafting business plans, assessing change controls, and leading cross-functional meetings. Competitive salary range of $59,700 - $126,800 annually, with comprehensive benefits packages offered.

Qualifications

• Hold a Bachelors degree in a relevant field.
• Experience managing multiple assignments and changing priorities.
• Ability to mentor cross-functional teams.

Responsibilities

• Develop and implement corrective actions for manufacturing operations.
• Assess proposed change controls against company standards.
• Coordinate change control documentation and cross-functional meetings.

Skills

Attention to detail

Organizational skills

Project management skills

Technical writing skills

Education

Bachelors degree in Life Sciences, Engineering or related field

Job description

We are currently looking to fill a Change Control Specialist position at BioSpace. This role develops strategic plans related to change control and implements corrective actions to support manufacturing operations by applying functional expertise. Current Department With Openings: Manufacturing.

Responsibilities

• Craft business plans to independently advance change control initiatives to implement Corrective and Preventative Actions (CAPAs) and process improvements in support of manufacturing operations
• Assess sophisticated proposed change controls to evaluate if proposal satisfies company standards
• Coordinate and prepare change control documentation that assesses and defines the scope, impact, risk, and regulatory impact associated with the change
• Review, edit, and revise controlled documentation in accordance with cGMP standards
• Coordinate and/or lead cross-functional meetings with multiple departments to drive change control implementation
• Provide advice and mentorship to cross-functional teams to enable successful and GMP compliant change controls
• Independently monitor and progress multiple projects concurrently identifying, addressing, and/or raising potential obstacles in a timely manner
• Present business critical and regulatory impactful change controls to senior leadership
• Document all training
• Assist with the training of new employees
• May manage direct reports

Desired Skills

• Excel in a quality-driven organization
• Can manage multiple assignments and changing priorities through robust organizational, planning, and project management skills
• Have a strong attention to detail
• Have strong technical writing and interpersonal communication skills
• Enjoy working in a fast-paced environment
• Have experience navigating a controlled quality system (preferred but not required)

Qualifications

To be considered for this role you must hold a Bachelors degree in Life Sciences, Engineering or related field and following minimum amounts of relevant experience for each level:

• Associate Specialist 0-2 years
• Specialist 2+ years
• Sr Specialist 5+ years

May substitute proven experience for education requirement. Level is determined based on qualifications relevant to the role.

Compensation and Benefits

Salary Range (annually): $59,700.00 - $126,800.00

We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.