Specialist I, Quality Engineer

Location
Baltimore (Camden), MD, US
Posted
Oct 05, 2020
Ref
666249800
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.

JOB SUMMARY
Represents Quality Assurance when participating in site projects as needed. Reviews and approves documentation related to validation, calibrations, work orders, computerized systems and other procedures requiring quality approval. Understands computerized systems and data integrity requirements. Supports team in review and revision of procedures as necessary.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
  • Assists in decision-making regarding requirements for validation, facilities and maintenance and computerized systems projects
  • Reviews and approves validation, technical documents, facilities and maintenance documents (i.e., work orders, calibrations, preventive maintenance, computer systems).
  • Understands the requirements of Data Integrity and can assist employees at the site in acquiring this skillset.
  • Serves as a change agent for continuous improvement within the scope of work.
  • Frequently interacts with direct manager, internal and external customers and other cross functional peers to gain alignment on sound quality decisions.
  • Assists in conducting system audits of departments as requested.
  • Provides support during regulatory and internal inspection activities as needed.
  • Coordinates/leads cross-functional teams in process mapping and other exercises designed to facilitate process and system understanding.
  • Provides support for change control meetings and closures.
  • Manages department projects as assigned.
  • Supports the needs of clients as requested (CMC, annual product reviews, client filings)

GXP DUTIES
  • Ensures compliance with the requirements of current Good Manufacturing Practices (cGMP).
  • Ensures the initial and continued training requirements are met.
  • Establishes, implements, and maintains departmental procedures consistent with company policies and standards for hygiene, safety, and security to assure compliance with applicable regulations, guidance documents, and industry best practice.

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
  • Minimum BSc. in Science, Pharmacy, or Engineering.
  • Minimum 8 years in an FDA regulated industry
    The position will interact with all levels of personnel, have a strong and assertive personality, possess well-developed negotiation skills, yet be flexible as required by the business needs. He/She must demonstrate ethical behavior during all phases of the job. The position requires the capacity to integrate technical detail, regulatory and quality standards and business judgment into concrete requirements and action priorities. All decisions must be managed through cycles of cause and effect analysis, corrective actions and prevention based.
  • The position requires excellent communication, human relations, management and organizational skills. The position must demonstrate a strong commitment to teamwork, empowerment, innovation and entrepreneurial culture.


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 does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by 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.