In this role, a typical day might include the following:

• Craft business plans to independently advances change control initiatives to implement Corrective and Preventative Actions (CAPA’s) 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

This role might be for you if you:

• 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).

To be considered for this role you must hold a Bachelor’s 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.