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30 days old

Quality Control Scientist

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


**Bristol, PA**


**Full Time**


**Saturday-Tuesday OR Thursday-Sunday**


**10hr Shift**


Kelly Science & Clinical is hiring a **Quality Control Scientist** with one of our global biotherapeutic and drug development clients to work in **Bristol, PA** .


**Responsibilities**


+ 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

+ 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


**Qualifications**


+ BS degree in a relevant discipline (e.g., chemistry, biological sciences, bioengineering, etc.)

+ Practical knowledge in all aspects of product development from investigational phase to commercial

+ Experience in the establishment and operation of QC laboratories in a GMP regulated environment

+ Minimum 5 years experience working in a GMP laboratory environment

+ Experience in 21 CFR part 211 and applicable FDA/ICH guidelines

+ Working knowledge of U/HPLC, GC, Karl Fisher, UV-Vis, FTIR, SDS-PAGE, ELISA, CE, and compendial assays

+ Ability to multitask and work well under pressure

+ Data Trending and control chart interpretation

+ The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job

+ While performing the duties of this job, the employee is regularly required to frequently lift and or move objects up to 20 pounds

+ 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: 2022-07-15 Expires: 2022-08-15

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Quality Control Scientist

Kelly Services
Bristol, PA 19007

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