Specialist I, QA

Location
Baltimore (Bayview), MD, US
Posted
Oct 01, 2020
Ref
680000600
Hotbed
BioCapital
Required Education
Bachelors Degree
Position Type
Full time
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 Specialist I, QA is responsible for assisting and supporting Quality Assurance activities in support of Phase I, II, III and commercial manufacturing of biotechnology products. The employee will have a potential for growth and development in all areas of quality support such as supporting internal/external inspections, validation protocol and report approval, document control, supply chain management, as well as supporting change control, investigations and corrective and preventative actions. The incumbent may interact with external CMO clients, senior leadership, direct manager, peers, internal customers and other cross functional peers across Emergent to gain alignment on sound quality decisions.

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

• Technical and quality review of validation protocols and reports.
• Support/execute QA on the Floor program.
• Support/execute Raw Material release.
• Support/execute Batch Record review of executed/Master Batch Records.
• Support/execute revision and creation of Standard Operating Procedures in document management system.
• Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA.
• Support QA oversite for incoming commercial and clinical projects.
• Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.
• Support the generation of QA operations metrics.
• Approve Quality Notifications (Deviations, CAPA's and Change Controls).
• Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues.
• Receive assignments in the form of objectives to help achieve department goals
• Support Quality Management systems as assigned (Training, Audits, Document Management, Supplier Quality).
• Participate in company sponsored training.
• Support regulatory and client audits.
• Provide Quality input/support to investigations, CAPA's and changes.
• Support site inspection readiness strategy and activities.
• Support internal audits per audit schedule.

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 and 8+ years of experience in GMP testing or manufacturing.
• Ideal candidate will have previous roles that leverages technical expertise in supporting validation, manufacturing or analytical laboratory testing.
• Minimum of 5 years' experience supporting GMP manufacturing; conducting facility/lab walkthroughs, supporting a QA on the Floor Program, releasing raw materials in SAP, identifying compliance risk and gaps, providing Quality input/oversight of potential manufacturing/lab deviations and performing batch record review on executed/master batch records.
• Preferred experience in biologic drug substance manufacture.
• Experienced in application of GMP principles, Minimum of 1 year in an FDA regulated industry.
• Strong computer skills with the Microsoft Office product line.
• Moderate understanding of regulations governing document control and records management.
• Ability to effectively communicate (orally and written) with all levels of personnel at multiple company locations.
• Experienced with US, EU and Canadian pharmaceutical regulations, ISO standards.
• Strong communication skills: oral/written and listening.
• Ability to work individually and in a team environment.
• Ability to work under pressure and analyze processes within scheduled timeframes.
• Strong presentation skills, including written and verbal communication skills.
• Experience in SAP and Technical Writing.

IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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.