QA Specialist II
- Full-Time
- Rockville, MD
- Emergent Biosolutions
- Posted 3 years ago – Accepting applications
Job Description
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.
II. JOB SUMMARY
The QA Specialist II in the Quality Assurance department of the Rockville site is responsible for critical independent reviews and QA release of finished product and Quality Assurance oversight of manufacturing activities which require a high-level quality experience.
Additionally, this position may be responsible for QA oversight of Quality Management Systems (deviation investigation, CAPA, and Change Control).
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Serve as reviewer and approver for protocols and reports relating to manufacturing process, validation, and other studies.
Serve as expert reviewer for studies, reports, project plans, regulatory submissions, and other document relating to process understanding, characterization, and validation.
Participate in batch release and all quality systems associated with batch release:
Review of manufacturing and testing records to ensure compliance to site procedures, regulatory requirements, and product license requirements.
Review deviation investigations, including root cause analysis.
Support the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps.
Coordinate and support the development and execution of change control plans to ensure compliant implementation of product and/or process changes.
Critically review various types of documentation to ensure completeness, accuracy, and compliance, including: SOP revisions, protocols, data sets, material specifications, work orders, calibration records, and validation reports.
Represent the department in interactions with internal functional units and external clients, or regulatory officials during site audits as needed.
Serve as point person for clients requiring assistance in preparation and/or review of regulatory submissions, Annual Product Reviews, client change notifications, and Quality Agreements.
Technical lead / support for site inspections from clients and regulatory agencies including escorting inspectors, speaking as Quality Assurance subject matter expert, and preparing documentation for auditor review .
Respond to internal and external audit findings.
Perform gap assessments of site systems and processes against corporate standards, and applicable regulatory requirements.
Facilitate the identification, gathering, analysis and reporting of Quality System performance metrics via the Quality Management Review process, including in-depth analysis of metrics and presentation to the site leadership team.
Revise Quality Assurance SOPs as required to ensure procedures are compliant with CGMP.
Provide technical mentoring and coaching to departmental and site staff in regards to CGMPs and worldwide regulations .
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
BA/BS (preferably in an Applied Science) or equivalent work experience.
Minimum 8 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, Gowning for BSL-2/3 and previous Quality Assurance experience preferred.
Expert knowledge of scientific principles and concepts.
Candidate must exhibit strong interpersonal and communication skills.
Strong oral and written communication skills.
Ability to work independently and in a team setting with minimal supervision.
Ability to make sound decisions regarding compliance-related issues with minimal supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ability to work on complex problems in which analysis of situation or data requires an in-depth evaluation of various factors.
Strong leadership, high level of personal/departmental accountability and responsibility and ability to Act as an approved delegate of the Quality Assurance Management Team (Supervisor/Manager)
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.
Apply to this Job
II. JOB SUMMARY
The QA Specialist II in the Quality Assurance department of the Rockville site is responsible for critical independent reviews and QA release of finished product and Quality Assurance oversight of manufacturing activities which require a high-level quality experience.
Additionally, this position may be responsible for QA oversight of Quality Management Systems (deviation investigation, CAPA, and Change Control).
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Serve as reviewer and approver for protocols and reports relating to manufacturing process, validation, and other studies.
Serve as expert reviewer for studies, reports, project plans, regulatory submissions, and other document relating to process understanding, characterization, and validation.
Participate in batch release and all quality systems associated with batch release:
Review of manufacturing and testing records to ensure compliance to site procedures, regulatory requirements, and product license requirements.
Review deviation investigations, including root cause analysis.
Support the development and execution of CAPA plans to address identified deviation root causes or compliance/quality gaps.
Coordinate and support the development and execution of change control plans to ensure compliant implementation of product and/or process changes.
Critically review various types of documentation to ensure completeness, accuracy, and compliance, including: SOP revisions, protocols, data sets, material specifications, work orders, calibration records, and validation reports.
Represent the department in interactions with internal functional units and external clients, or regulatory officials during site audits as needed.
Serve as point person for clients requiring assistance in preparation and/or review of regulatory submissions, Annual Product Reviews, client change notifications, and Quality Agreements.
Technical lead / support for site inspections from clients and regulatory agencies including escorting inspectors, speaking as Quality Assurance subject matter expert, and preparing documentation for auditor review .
Respond to internal and external audit findings.
Perform gap assessments of site systems and processes against corporate standards, and applicable regulatory requirements.
Facilitate the identification, gathering, analysis and reporting of Quality System performance metrics via the Quality Management Review process, including in-depth analysis of metrics and presentation to the site leadership team.
Revise Quality Assurance SOPs as required to ensure procedures are compliant with CGMP.
Provide technical mentoring and coaching to departmental and site staff in regards to CGMPs and worldwide regulations .
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
BA/BS (preferably in an Applied Science) or equivalent work experience.
Minimum 8 years of experience working in a cGMP manufacturer, Aseptic Manufacturing, Gowning for BSL-2/3 and previous Quality Assurance experience preferred.
Expert knowledge of scientific principles and concepts.
Candidate must exhibit strong interpersonal and communication skills.
Strong oral and written communication skills.
Ability to work independently and in a team setting with minimal supervision.
Ability to make sound decisions regarding compliance-related issues with minimal supervision. Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
Ability to work on complex problems in which analysis of situation or data requires an in-depth evaluation of various factors.
Strong leadership, high level of personal/departmental accountability and responsibility and ability to Act as an approved delegate of the Quality Assurance Management Team (Supervisor/Manager)
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.