Specialist II, Quality Assurance

Location
Canton, MA, US
Posted
Dec 23, 2020
Ref
700971700
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 QA Specialist II professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Rockville Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist II will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required.

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

• Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.
• Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data
• Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)
• Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges
• SOP generation, review and/or approval
• Own quality records (Deviation/CAPA/Change Control).
• Manage and support the Complaint program
• APR generation and approval
• Must be capable to work independently and strategically to ensure day¬¨ to-day activities are carried out in support of the business goals
• Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.
• Lead and support additional work as required.

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 Scientific or related fields
• A minimum of seven (7) years of cGMP Quality experience
• Product and Raw material disposition is a must
• Well versed in SAP is a must
• Batch Record review is a must
• Strong Commercial manufacturing experience (Large Molecules) required
• Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must
• Experienced with US, EU pharmaceutical regulations, and ISO standards
• Expert Knowledge and application of GMP principles
• Excellent communication skills: oral, written and listening
• Ability to influence without authority across cross-functional organization

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.

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