Consider joining Eurofins Lancaster Laboratories where people are the most important element in our chemistry. Celebrating 50 years of service, Lancaster Laboratories is a leading contract lab providing testing and research services in the environmental, pharmaceutical, and biopharmaceutical sciences to clients worldwide.
Scientist, Quality Documents responsibilities include, but are not limited to, the following:
QualificationsThe ideal candidate would possess:
- Manage Quality documentation through the implementation and quality review lifecycle.
- Establish and update SOPs, training materials, and other quality documents to support a GMP manufacturing facility
- Author learning content using established templates
- Partner with community peers at the operational sites to get feedback on materials to be deployed
- Routinely interface with internal staff to incorporate feedback into workable final versions
- Process workflows in the information system for document management
- Routinely present information to project team related to site review status, needed resources and/or roadblocks
- Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to path forward
- Management of multiple projects and concurrent timelineswhileadhering to standard timelines, and escalating actions appropriately for resolution in a timely manner
- Ability to process quality documents within an electronic system such as trackwise digital
- Advanced ability to use Microsoft Word, Excel and PowerPoint
- Actively develops and maintains strong professional relationships building trust and respect across the organization
- Lead through influence, effectively build alignment and collaborate with multiple stakeholders
- Assess performance roadblocks, escalate and propose appropriate solutions
- Proficiency with technical writing in cGMP or FDA regulated manufacturing environment
- Ability to work in a fast paced environment and manage multiple projects and objectives for on-time deliverables
- Must work well on a team and be able to troubleshoot and problem solve in a cross-functional team setting
- Must be proactive, action oriented, and adapt to change
- Able to identify and flag risks in a timely manner to keep deliverables on track
- Strong written and verbal communication skills
- Ability to read and comprehend complex subjects
- Ability to understand and apply GMP regulations as they relate to pharmaceutical manufacturing
- BS in scientific discipline such as Biochemistry, Chemistry, Biology or related discipline
- Minimum of 2+ years' experience conducting investigation and root cause analysis in a pharmaceutical or FDA/GMP environment required
- Experience with GMP compliance in clinical/commercial manufacturing environment is required
- Experience with quality management software (Mastercontrol, Trackwise, etc.) is preferred
- Experience with asset management software (Blue Mountain, Maximo, etc) is preferred
- Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, working Monday through Friday, 8:00 a.m. - 5:30 p.m., with overtime as needed.What we offer:
- Comprehensive medical coverage, with dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid holidays and vacation
Eurofins Lancaster Laboratories Professional Scientific Services®(PSS) is a global, award-winning insourcing solution that places our people at our clients' site dedicated to running and managing laboratory services while eliminating headcount, co-employment and project-management worries.
We infuse our 55-year track record of scientific and laboratory operations expertise, as well as HR and great place to work best practices, to recruit, hire, train and manage highly qualified scientists to perform laboratory services using our client's quality systems and equipment.We are looking forward to receiving your application including your expected salary and possible start date via our career website.Eurofins is aM/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.
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