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1+ months

Quality Control Scientist

Kelly Services
Bristol, PA 19007
**Quality Control Scientist in Bristol, Pa**


Kelly Science is the worlds 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

+ Benefits100% 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 interestsits 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, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2022-04-01 Expires: 2022-06-02

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Quality Control Scientist

Kelly Services
Bristol, PA 19007

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