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Analyst III, QA Compliance

Emergent Biosolutions, Inc.

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Canton, MA
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Job Description

As posted by the hiring company

Job Overview:


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.

JOB SUMMARY

The QA Compliance Specialist I will handle day to day activities related to supplier quality management including the processes for supplier and/or material change notifications and supplier corrective action requests. Lead weekly meetings and manage all communication surrounding status of work especially any critical and/or at-risk material and supplier changes with a sense of urgency. Additionally, the Specialist I will monitor and ensure Canton suppliers are qualified as required per Global procedure. Update at daily MDI boards, generate monthly Quality Management Review metrics, and quarterly site supplier status reports. This is a highly collaborative position that works closely with Global Quality and site functions including Quality Control, QA Operations, Manufacturing, and Supply Chain to foster communication and resolve challenges efficiently. Experience using a risk-based approach for prioritization and working knowledge of applicable industry guidance documents is required.


ESSENTIAL FUNCTIONS

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

  • Support routine and non-routine work related to Supplier Quality Management. This includes but is not limited to:
  • Receive, track, and initially evaluate impact of supplier and/or material change notifications both internally and from suppliers.
  • Maintain supplier dashboard to reflect up to date information and communicate critical or at-risk issues real-time.
  • Lead weekly Supplier Committee meeting to effectively identify action items and progress, and subsequently distribute the outcome of this meeting to site stakeholders.
  • Review and complete material classification forms for Compliance agreement.
  • Collaborate cross-functionally to facilitate progress for specific material/ supplier changes as needed.
  • Initiate internal Supplier Corrective Action Requests cross-functionally to ensure completeness and accuracy, then work with the supplier to ensure timely resolution.
  • Monitor and report monthly metrics to Quality Management Review to convey key performance indicators.
  • Monitor and report quarterly status of Canton suppliers to Compliance Director and Site Quality Head to ensure appropriate supplier qualification has been completed with respect to risk level, quality agreement, and audit. Where deficiencies exist proactively work with Global QA to resolve.
  • Seek to continuously improve and streamline supplier quality management processes while increasing collaborative and proactive supplier relationships.
  • Support regulatory inspections, as necessary.
  • Consistently interact with direct manager, peers, internal customers, and other cross functional peers across Emergent to gain alignment during routine work.
  • Demonstrate team-work and inter-personal skills to ensure quality and compliance concerns are resolved in an efficient and timely manner.
  • Utilize education, experience, skills and training or a combination thereof to ensure site compliance with applicable regulatory requirements (e.g., 21CFR210-211, 21CFR600-610, ICHQ7, ICHQ9 and ICHQ10, cGMP principles, FDA Guidance for Industry: Data integrity and Compliance with CGMPs).


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 scientific or related field.
• A minimum of four (4) years of cGMP Quality experience.
• Strong commercial manufacturing experience, biologics preferred.
• Knowledge of applicable CGMP regulatory requirements e.g., 21CFR210-211, ICH Q7 Guidelines, and application of regulatory requirements required.
• Excellent communication skills: oral/written and listening.
• Excellent facilitation and presentation skills.
• Excellent Interpersonal skills: team building, consensus building, conflict resolution.
• Personal Competencies: attention to detail, self-awareness, integrity, decision making, adaptability, sound judgement.
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Visio.
• Ability to influence without authority across cross-functional organization.

Successful applicants for this position that are required to be onsite at any Emergent site at any time, must be fully vaccinated against COVID-19 as a condition of employment, subject to legally required exemptions.

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.