Planet Pharma ยท 1 day ago
Quality Control Specialist
Berkeley, CA
Contract
Onsite
Senior Level
$30/hr - $34/hr
6+ years expPlanet Pharma is seeking a Quality Control Specialist to support the implementation of new methods in their Quality Control Chemistry department. The role involves performing method feasibility studies, method development, and laboratory assays for method validation while ensuring compliance with safety guidelines and regulations.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Supports implementation of new methods in Quality Control Chemistry department
Maintains appropriate logs, notebooks and other records including electronic documents
Performs method feasibility studies, method development, and performs laboratory assays for method validation protocol execution utilizing various chemistry instrumentations (HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter)
Thorough knowledge of chromatography (SEC, ION, NORMAL, REVERSE, ION- PAIR, etc), electrophoresis (PAGE and/or agarose), simple chemistry methods (e.g., spectrophotometry) and wet chemistry to prepare samples. Knowledge of biologics and manufacturing processes
Troubleshoots assays and analytical instrumentation needed for method performance including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter
Generates method development reports and method validation reports
Understands and follows SOPs, pharmacopoeias, regulations, and safety guidelines
Able to follow GDP and GMP practices
Capable of managing multiple tasks, working effectively with more than one technical leads, interfacing with other functions such as manufacturing and research personnel
Qualification
Required
Supports implementation of new methods in Quality Control Chemistry department
Maintains appropriate logs, notebooks and other records including electronic documents
Performs method feasibility studies, method development, and performs laboratory assays for method validation protocol execution utilizing various chemistry instrumentations (HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter)
Thorough knowledge of chromatography (SEC, ION, NORMAL, REVERSE, ION- PAIR, etc), electrophoresis (PAGE and/or agarose), simple chemistry methods (e.g., spectrophotometry) and wet chemistry to prepare samples
Knowledge of biologics and manufacturing processes
Troubleshoots assays and analytical instrumentation needed for method performance including HPLC, UPLC, KF Titrator, Autotitrator, Melting Point meter, Chloride meter, Polarimeter
Prior experience in a QC laboratory and hands on experience with LIMS, SAP and related chromatographic software (EMPOWER)
Generates method development reports and method validation reports
Understands and follows SOPs, pharmacopoeias, regulations, and safety guidelines
Able to follow GDP and GMP practices
Capable of managing multiple tasks, working effectively with more than one technical leads, interfacing with other functions such as manufacturing and research personnel
Bachelor's Degree in a science or technical field
Minimum 6 years of experience or a Masters degree and 2 years of experience or a PhD and zero years of experience in pharmaceutical or related industry or an equivalent combination of education and experience
3+ years experience in the relevant (business need) technical and logistical specialty
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase