job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Swiftwater, Pennsylvania
job type: Contract
salary: $41.62 - 48.96 per hour
work hours: 9 to 5
responsibilities: Job Responsibilities
- Deviation System point of contact for FFIP, primarily within the Filling and Inspection areas.
- Individual contributor that is responsible for timely closure of lot related and other deviations and thus has significant regulatory impact in supporting FFIP in keeping in a compliant and audit ready state.
- Facilitates cross-functional interfacing activities with stakeholders in a very positive manner: Quality Control, Manufacturing Technology, Sterility Assurance, and Quality Assurance.
- Responsible for management and coaching of direct reports, facilitate deviation investigation process and assist in identifying appropriate corrective and preventive actions.
- Reviews deviations for completeness prior Director review
- Leads complex investigations using advance RCA tools (6Ms, Cause-Effect, Is-Is Not, 5Whys, kaizens, etc).
- Well versed in multiple type of investigations including HE, EM, Equipment, Customer Complaints.
- Responsible for delegation of department or functional area deviations to the appropriate PI's, and ensuring they are assessed and investigated in a timely manner, compliant with our SOP.
- Facilitates resolution to unresolved issues and deliverables by leading meetings, positively influencing functional manager, removing obstacles and managing projects and priorities, which are critical to ensuring critical lot release.
- Promotes professional development of self and direct reports by identifying opportunities in investigation methods, quality engineering, technical writing and applicable sciences that help equip the team to complete the mission.
- Develops and analyzes weekly status and trending reports and monitors and reports progress to FFIP and QA Compliance Management, and Planning in a most timely manner.
- Assures that operations are safe and in compliance with Quality Systems, cGMP, CBER, WHO, EP and other regulatory bodies.
- Required to possess and demonstrate excellent interpersonal/communication skills and management by influence skills, flexibility and the ability to lead and participate on teams.
- Conducts performance reviews for direct reports within the department.
qualifications: Education & Qualifications
- Bachelor level degree in Life Sciences or Business Administration with experience working within a production department of a pharmaceutical or Biotech Company.
- 3 - 5 years of experience in manufacturing and or development departments.
- Working knowledge of cGMP's.
- Candidate must be able to work overtime and flexible hours, including weekends.
- Deep understanding of cGMPs and manufacturing activities including: aseptic filling, lyophilization and visual inspection.
- Knowledgeable in lean manufacturing concepts and principles.
- Experience conducting root cause investigation and knowledgeable in the use of investigation tools like: brainstorming, cause and effect diagrams, 6Ms, Is/Is Not and others.
- Excellent technical writing skills as applied to the generation of investigation reports.
- Good project management and organizational skills.
- Proficient in Microsoft Office (Excel, Word and PowerPoint)
- Strong time management and prioritization skills
- Knowledgeable in ERP system (SAP preferred)
- Quality Management Systems (TrackWise)
- Root Cause Investigation Principles
- Six Sigma and Lean Manufacturing
- Technical Writing
skills: Quality control, SOP, FDA, Quality Assurance, CAPA, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.