Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a temporary opportunity to work as a Quality Project Manager – Pharmaceutical Manufacturing at a prestigious Fortune 500® company working in Baltimore, MD.
This is a 12-month temporary position at 40 hours per week. Pay: $55.00/hr.
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the “submit now” button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (email@example.com) however your resume must be received via the “submit now” button included within.
- Provide person-in-plant support for the tech transfer and GMP production of COVID Vaccine Drug Substance at Company, Baltimore, MD.
- Perform review and approval of equipment and facility qualification, technical documents, raw material specifications, analytical methods, and master batch records to ensure Company products and processes comply with cGMP requirements.
- Following successful tech transfer, support day-to-day quality oversight for production activities in the manufacturing plant, including identification of risks, deviation and CPA management, change control, and batch documentation review
- Support regulatory submissions and inspection readiness activities
- Build relationships and influence external partners to continuously enhance quality culture and business excellence
- Apply cGMP regulations and other FDA and international requirements to all aspects of the position.
Job Requirements (required):
- Bachelor's Degree with a concentration in engineering, science, or an equivalent technical discipline
- Minimum of 8 years working in an FDA regulated environment
- Experience with biologics manufacturing operations or quality assurance
- Experience in aseptic processing
- Detailed knowledge of cGMPs related to pharmaceutical production
- Strong interpersonal and written/oral communication skills
- Ability to quickly process complex information and make critical decisions with limited information required
- Advanced degrees are a plus and may reduce the experience required
Job Requirements (preferred):
- Experience in vaccines production
- Proficient in applying process excellence tools and methodologies
- Experience working with external manufacturers
- Up to 100% domestic travel required
Your engineering skills are in demand, but how do you find the right fit? Easy. With Kelly® Engineering, our experts connect you with leading organizations where you can learn and grow, collaborate on innovative projects, and keep your skills sharp with top technology. Whether you prefer the variety and flexibility of short-term projects, or are looking for something more long-term, we're here every step of the way to find your dream engineering job.About Kelly®
At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.
Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.]] About Kelly Services
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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