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.
The candidate will be responsible for managing Line A and B production-related deviations, CAPAs, CCs systems, Batch Records, and will ensure tasks/records are timely addressed and closed. Work closely with cross-functional departments subject matter experts (SMEs) to obtain pertinent information necessary to write/close deviations, providing expertise on necessary preventive measures, ensuring site deviation and CAPA metrics are in a controlled state, and will be the SME for defending relevant deviations in GMP audits (internal and external). This leader is accountable for performing duties in accordance with Standard Operating Procedures (SOP) and driving the performance management, training and development and continuous improvement of the PC team. The position requires superior leadership behaviors of the Emergent core competencies as well as expertise in functional competencies included in this position responsibilities.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
- Manage PC teams to ensure appropriate alignment of resources to support deviation/CAPA management and routine operational improvement
- Perform real-time BPR review and ensure timely closure of batch record approval.
- Track and trend all data relevant to the deviation/CAPA/CC systems/BPRs.
- Track and report status on KPIs relevant to deviations and ensure commitments to key stakeholders are met in a timely manner with the highest quality
- Build a strong working environment that promotes our core values and progresses our culture in a positive manner (healthy cross-functional teamwork)
- Capable of leading change in a positive manner
- Ability to identify and manage talent through requisite HR systems (hiring, compensation, performance management and development) in ways that provide value to both company and employees
- Manage the IPMP for direct reports and mentor associates to facilitate professional and departmental growth and ensuring accountability
- Good interpersonal and communication skills (oral and written)
- Demonstrates, understands and adheres to Emergent policies, GMP standards and safety procedures
- Identify and appropriately escalate issues that require decisional activity in order to keep routine operations, projects and initiatives on schedule
- Author, resolve, review and approve Deviations, Change Controls, CAPAs and additional documents to support production needs and meet product release requirements.
- Independently analyze complex issues using risk appropriate decision making.
- Demonstrate technical writing ability; capable of interpreting and citing specific procedures as it applies to investigation decision making and timely closure.
- Initiate tracking and follow up of more complex issues stemming from deviation investigations.
- Assist in the continuous reduction in generation of deviations by helping to implement effective preventative actions.
- Identification and facilitation of interdepartmental continuous process improvements.
Requires vaccination against different viruses including Vaccinia virus.
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
- Bachelor’s Degree in Science and/or related field
- Minimum of 5 years of technical writing experience in the pharmaceutical/biotechnology discipline.
- This is an exempt (salary) position.
- Expertly write technical deviations relating to manufacturing process and review documents with the following skills:
- Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices (cGMPs), CAPA, CC and regulatory guidelines.
- Experience overseeing personnel in a fast-paced environment
- Highly organized individual with strong attention to detail and great technical writing ability
- Good analysis, troubleshooting, investigation and communication skills, both written and verbal
- Working knowledge of root cause analysis tools and continuous improvement techniques
- Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report
- Ability to manage time and priorities effectively
- Ability to interface with others effectively at various levels in multiple departments, including customers
- Ability to work well independently and with minimum or no supervision and identify problematic deviations upfront
- High level of computer literacy, including MS Word and Excel
- Ability to work extended and flexible hours (including weekends) when needed
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.
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.