CAPA/CC Supervisor

Location: 

Baltimore (Bayview), MD, US, 21224


 

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

  1. JOB SUMMARY

 

The CAPA Supervisor position reports to the Sr. Manager of Manufacturing Compliance at Emergent Manufacturing Operations Baltimore (EMOB). The position is responsible for Batch Release, CAPAs, Change Controls, Deviations and Root Cause Analysis. This includes supervision of analyst staff, manufacturing budgets, developing standard operating procedures and training, interacting with other departments.

 

  1. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

 

  • Provides hands-on supervision of manufacturing staff, analysts in the operation of running root cause analysis meetings and writing and reviewing deviations.
  • Maintains performance standards and goals for Manufacturing Analysts
  • Demonstrates and enforces understanding and adherence to Emergent policies, GMP standards and safety procedures
  • Hires, evaluates, trains, and develops staff.
  • Oversees development and maintenance of management processes including, but not limited to:  Employee job descriptions, Integrated Performance Management Process (IPMP) documentation, staffing models, resource allocation models.
  • Effectively delegate decision making into the department.  Empower direct reports to make level-appropriate decisions.
  • Updates the Sr. Manager of Manufacturing Compliance on process status and achievement of objectives
  • Resolves problems of analyst staff and manages analyst resources
  • Interacts with other site group leaders including Sr. Director and VP level staff
  • Prepares and conducts technical presentations of manufacturing processes
  • Performs annual performance appraisals of staff reporting to the position
  • Generate Deviations, SOPs and Protocols as required
  • Works with subject matter experts to find root causes for minor, major and critical deviations, CAPAs and Change Controls
  • Maintains metrics for all Deviations, CAPAs, Change Controls, Batch review, and annotation resolution.
  • Supports Emergent QA during audits and regulatory inspections
  • Supports other manufacturing process teams and other EMOB groups as necessary to achieve Manufacturing team goals

 

 

 

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.

 

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

 

  • BS degree in biology, chemistry or related scientific or engineering field
  • Minimum 4 years of Root cause analysis and OE methodology preferred; Hands on experience leading root cause analysis meetings.
  • Computer literate (Word, Excel, Smartsheet and PowerPoint)

 

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
 

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce.  Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.
 

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .
 

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Lead with Integrity
    • We gain trust and confidence through ethics, quality, and compliance excellence
  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore