Bristol, Pennsylvania

Quality Control Scientist in Bristol, Pa

Kelly Science is the world’s most recognized brand in Scientific Staffing with more than 5,000 scientists on assignment daily. We are currently recruiting for Quality Control Scientists to work onsite in Bristol, PA in a temp-to-hire capacity. After conversion, this company provides 100% employer paid medical benefits.

The Quality Control Scientist is responsible for training and supervisor of Quality Control Associates as well as more complex sample analysis as well as investigations, and process improvements/CAPAs.

 

Responsibilities

  • The QC Scientist will be responsible for building the Quality Control (QC) GMP infrastructure
  • Oversight of method qualifications and validations, out of specification/anomalous results investigations
  • Lead process improvements
  • Train and mentor QC Associates
  • Manage QC GMP laboratory, as required including equipment/material/reagent/supply ordering, and inventory control
  • Assist in release of raw materials, in-process materials, intermediates, APIs and finished products and perform (per test method or Compendia Requirements) quantitative analysis and data analysis of raw materials, in-process samples, GMP intermediates, final bulk drug substance, and stability samples
  • Maintain QC laboratory including adhering to schedules for calibration and maintenance of equipment as well as issuance of change controls, as appropriate
  • Conduct OOS, OOT, non-conformance, risk assessment, gap analysis, investigation, and review of deviations, OOT, and implementation of CAPAs and root cause investigations and/or assist management of these investigations
  • Author and review Standard Operating Procedures (SOPs), technical documents, protocols, and reports
  • Maintain laboratory notebook according to good documentation practices
  • Assist facility manager ensuring timely calibration of equipment
  • Review qualification of equipment, performed by qualified vendors
  • Qualification, transfer, validation, and routine execution of analytical methods for small molecule, protein, and antibody drug conjugate (ADC) compounds
  • Sample types may include raw materials, in-process materials, intermediates, APIs, finished products, related substances, stability samples, cleaning verifications, etc
  • Analytical techniques may include UV-visible spectroscopy, RP-LC, SEC, HIC, CEX, SDS-PAGE, Western Blotting, HPLC/UPLC, LC-MS, q-TOF, capillary electrophoresis, ELISA, peptide mapping, SEC-MALS, DSC, MFI, DLS, cIEF, CD, Karl Fischer, FTIR, pH, conductivity, osmolality, appearance, etc
  • Documentation of work in laboratory notebooks and logbooks according to organizational GDP policies
  • Maintenance, cleaning, calibration, troubleshooting, and repair of analytical instruments and equipment
  • Management of work carried out by third-party analytical and metrology service providers
  • Adhere to EHS and quality standards set by regulations and company policies, procedures, and mission
  • Operate to the highest ethical and moral standards
  • Participate effectively as a team player
  • Work with other teams to determine analytical methods and instruments needed to support GMP manufacturing
  • Communicate effectively with supervisors, support staff, colleagues, clients, vendors, etc
  • Attend, contribute to, and lead relevant meetings
  • Prioritize, plan, and manage their own work schedule effectively and efficiently
  • Keep up to date with EHS, cGMP, scientific, and technical developments
  • Evaluation of lab practices for continuous improvement
     

Requirements

  • Bachelor of Science (Chemistry strongly preferred)
  • 2-4 years’ experience in QC laboratories in a GMP regulated environment
  • Strong experience in U/HPLC, GC, Karl Fisher, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays
  • Knowledge in all aspects of product development
  • Data Trending and control chart interpretation knowledge

 

Details

  • Temp-to-Hire (6-8 months to conversion)
  • First shift 9am-5pm, or noon-8pm
  • Benefits—100% employer paid on conversion
  • $27-$36/hr

 

 

While performing the duties of this job, the employee is regularly required to frequently lift and or move objects up to 20 pounds and
• Must have the ability to stand/walk during entire length of shift
• Use of arms, hands and fingers to handle, feel or reach
• Ability to climb, balance, stoop, kneel, crouch, or crawl
• Visual abilities include close, distance, color, peripheral, depth and ability to focus



You should know: Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.

Why Kelly®?

Kelly® Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interests—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

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, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

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Bristol, Pennsylvania

Why Kelly - Since 2011 we have placed over 16,000 Veterans

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Kelly applies targeted recruiting initiatives to the Veterans population (in all stages of transition) by aligning customer defined requirements with military skills and experience.  The transition from military to civilian life can be stressful and complex for veterans, and our staff is trained to assist in this transition.  Unlike our competition, Kelly places these resources without geographic or industry constraints, offering our customers and our employees greater flexibility.  Kelly has a wide variety of local opportunities, for Veterans and their spouses, within our workforce solutions as well as national recruiting programs on behalf of our customers.  Kelly’s leading placement opportunities for Veterans are within Information Technology, Engineering, Science, Light Industrial and Call Center.

Our specially trained Veteran recruiters are armed with a number of tools to help Veterans obtain roles that match their potential including skill translation tools, leading Veteran- centric job boards and Veteran/spouse social media networks, among others.

Through Kelly’s vast branch network, we are closely located to the majority of major military installations across the United States.  Kelly recruiters participate in onsite and virtual military career fairs as well as advertise through local and national Veteran job boards.  In recent years, over 150 Kelly branches have worked directly with their local military installations to recruit spouses and transitioning personnel.  These teams not only engages with transitioning talent from local bases, but also have a strong focus on Veterans in areas where the military has identified high Veteran unemployment. This approach ensures that military talent is engaged and shared across the centralized military recruiting team and documented in a centralized database, so that other Kelly locations can benefit from hiring or relocating this valuable pool of talent.

Our focus on military recruiting is a win on multiple levels. Kelly gains top talent with the skills needed to excel; our clients receive the benefit of that talent to help them compete in an ever challenging business landscape; and Veterans receive gainful employment in line with their skills and abilities to ease the transition to the next phase of their lives.

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Kelly founded the temporary staffing industry in 1946, and has maintained a leadership position through the years based on a valuable premise: we invest in people. Today that focus benefits our customers wherever they operate around the globe - in a growing number of specialized fields. And we’ll continue to meet the evolving challenges of workforce flexibility with staffing solutions tailored to your precise business needs, both locally and worldwide.

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