Supervisor, Quality Assurance, Shop Floor (2nd Shift)
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.
I: JOB SUMMARY
The Quality Assurance Supervisor (QA Supervisor), On the Floor (OTF) provides quality oversight and management for the Bayview Quality OTF functions to ensure patient safety and compliance with FDA and other applicable health authority requirements. In addition, the QA Supervisor provides input for continuous improvement and reporting/escalation of quality issues and/or risk mitigation activities. Finally, the QA Supervisor fosters a culture of quality and compliance through effective leadership and strict adherence to Emergent core values. The supervisor has direct oversight over the QA OTF personnel.
II: ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• The Quality Assurance Supervisor supports the QA Management team by supervising a group of QA Associates with the primary responsibility of on the floor compliance activities.
• The QA Supervisor represents QA at meetings and provides GMP oversight of operational activities.
• The QA Operations Supervisor is primarily responsible for:
o Shop floor Quality review of batch records
o Quality oversight of Operational activities
o Commercial and Clinical Product Quality oversight
o Review and assess Quarterly Trend data
o Compliance with GMP requirements, good documentation practices and adherence to Emergent’s procedures
o Training of Quality Assurance Associates
• Ensuring that systems and processes supporting lot release and on the floor activities are up to date and compliant with regulatory requirements.
• Lead the QA OTF team to assure good alignment with client expectations and on-time batch delivery according to plan, including the management of the team to provide 24/7 coverage of manufacturing operations.
• Must have a strong working knowledge of cGMPs as they relate to Batch Production Record adherence, Good Documentation Practices (GDP), and compliant manufacturing of GMP materials. Must also possess the knowledge to support deviation investigation/resolution and generation/implementation of identified CAPAs.
• Strong computer skills and understanding of SAP, eQMS or similar electronic inventory management system.
• Lead daily operational initiatives. The successful candidate will have a proven track record of operational execution while retaining high quality of the deliverables.
• Work effectively with various Site functions to align systems across the site.
• Participate in interdepartmental and operational excellence initiatives. Interact with other functional areas to define and execute project requirements and objectives and maintain compliance across the site. Candidate must have track record of working effectively in teams to resolve issues and elevate as appropriate. Ability to prioritize and multitask necessary.
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
• Bachelor’s Degree in Biology, Chemistry, Engineering, or related fields
• A minimum of five (5) years of cGMP Quality experience (QA/QC/Manufacturing)
• Strong communication skills: oral/written and listening
• Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
• Interpersonal skills: team building, consensus building, conflict resolution
IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.