- Maintain client confidentiality and ensure that any documents received for audit are controlled, protected and secured.
- Audit QPS SOP(s) to ensure contents meet regulatory requirements and interpretations.
- Review equipment and laboratory records, and Employee Qualification Manuals to ensure compliance with SOPs
- Audit study records and reports to ensure they accurately reflect the protocol/amendments, SOP(s), procedures and actual data results obtained during the study.
- Compare analytical procedures to the protocol and validated methods to ensure proper study conduct.
- Identify noncompliance and deviations, and recommend corrective and preventative actions in an educational and persuasive manner.
- Issue audit reports to disclose noncompliant findings to Principal Investigator, Study Director and Management and verify their follow-up responses are adequate and complete to close the audit.
- Assist with client and government audits or any department goals as requested by supervisor or manager
- Ability to understand and comply with GLP regulations, principles and Guidance Documents.
- Ability to identify resources and use them to formulate solutions, make decisions and implement them.
- Ability to anticipate and identify critical issues or problems and recommend solutions.
- Ability to deal with conflict and drive resolution independently or through proper chain-of-command.
- Effective verbal and written communication skills.
- Proven ability to exercise good judgment and effectively balance work activities and changing priorities.
- Bachelor's degree in Chemistry, Biochemistry, Pharmacology or related scientific discipline preferred
- ≥ three (3) years experience working in a regulatory environment or position (GLP, GCP or GMP), a plus
- Experience in mass spec chromatography and/or ELISA and familiarity with various lab equipment are preferred but not absolute requirements.
-
Mqsa Associate Scientist
1 week ago
Johnson & Johnson West Chester, United States**DePuy Synthes **, is recruiting for an **MQSA Associate Scientist **, located in **West Chester, PA.** · About Johnson & Johnson · **Job Summary** · As an Associate Sterilization Scientist, you will join our dynamic team of experts in the field of sterilization. You will be res ...
-
Associate Scientist I
1 week ago
QPS, LLC Newark, United StatesJob Description · Job DescriptionDo you want to be part of an organization that is making a difference in the lives of millions of people worldwide? If so, we want to hear from you QPS, LLC has an opening for an Associate Scientist I in our GBA group. In this role, you will play ...
-
Associate Scientist/scientist
6 days ago
Frontage Lab Exton, United States Full timeAssociate Scientist/Scientist - Biologics Service FTE team · Full Time · Exton PA or Client's site at Spring House PA · Frontage Laboratories · Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development services throu ...
-
Associate Scientist/scientist
1 week ago
Frontage Laboratories Exton, United StatesJob Description · Job DescriptionAssociate Scientist/Scientist – Biologics Service FTE team · Full Time · Exton PA or Client's site at Spring House PA · Frontage Laboratories · Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, p ...
-
Associate Scientist/Scientist
1 week ago
Frontage Laboratories Exton, United StatesJob Description · Job Description Associate Scientist/Scientist – Protein Biochemist · Full Time · Location at Spring House PA · Frontage Laboratories · Frontage Laboratories is a CRO / Clinical Research Organization providing integrated, science-driven, product development servi ...
-
Associate Scientist
1 week ago
Intepros Consulting Exton, United StatesIntePros is currently looking for an Associate Scientist to join a leading designer and manufacturer of medical products in Exton, PA. In this role, the Associate Scientist will support multiple internal and external customers under guidance and supervision (either Manager or Sr ...
-
Associate Scientist
6 days ago
Frontage Laboratories Exton, United StatesAssociate Scientist/Scientist- Cell-Based Assay Core Facility · Title: Associate Scientist/Scientist · Location: Exton PA · Reports to: Associate Director, Core lab of Cell-based assay · Full-time · Frontage Laboratories · Frontage Laboratories is a CRO / Clinical Research Organ ...
-
Scientist/Associate Scientist- Biomarker
1 week ago
Frontage Lab Exton, United StatesFrontage Laboratories: · Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within the USA, Canada, and China. Fronta ...
-
Scientist/Associate Scientist- Biomarker
1 week ago
Frontage Laboratories Exton, United StatesJob Description · Job DescriptionFrontage Laboratories: · Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within t ...
-
Scientist/Associate Scientist- Biomarker
1 day ago
Frontage Laboratories Exton, United States OTHERJob DescriptionJob Description · Frontage Laboratories: · Frontage Laboratories Inc. (Frontage), is a global contract research organization with broad expertise in supporting pre-clinical and clinical drug development. Frontage operates out of several different locations within t ...
-
MQSA Associate Scientist
1 week ago
Johnson & Johnson West Chester, United StatesDePuy Synthes , is recruiting for an MQSA Associate Scientist , located in West Chester, PA. · About Johnson & Johnson · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, ...
-
Associate Scientist-Biologics
1 week ago
Frontage Lab Exton, United StatesAssociate Scientist-Biologics · Exton, PA (Corporate) · Responsibilities: · * Coordinate study activities with Responsible Scientist to ensure efficiency and quality · * Aid in the preparation of study summaries and/or reports · * Maintain the proper level of regulatory complianc ...
-
MQSA Associate Scientist
1 week ago
J&J Family of Companies West Chester, United StatesMQSA Associate Scientist W · **Description** · **DePuy Synthes** , is recruiting for an **MQSA Associate Scientist** , located in **West Chester, PA.** · About Johnson & Johnson · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empower ...
-
Associate Scientist I
1 week ago
Insight Global Malvern, United StatesOur large pharmaceutical client is seeking to bring on an Associate Scientist to join their growing API Large Molecule Process Development group in Malvern PA. This individual will be performing cell banking for the cell culture processes and bio-analytical testing. This individu ...
-
Associate Scientist-Biologics
1 week ago
Frontage Laboratories Exton, United StatesJob Description · Job DescriptionAssociate Scientist-BiologicsExton, PA (Corporate) · Responsibilities:Coordinate study activities with Responsible Scientist to ensure efficiency and quality · Aid in the preparation of study summaries and/or reports · Maintain the proper level of ...
-
Frontage Laboratories Exton, United StatesJob Description · Job DescriptionAssociate Scientist/Scientist, BCGT Analytical Development · Title: Associate Scientist/Scientist, BCGT Analytical Development · Location: 760 Pennsylvania Dr. Exton, PA · Reports to: Director, BCGT Analytical Development · Full-time · Frontage L ...
-
Associate Scientist, Bioanalytical Services
1 week ago
Frontage Lab Exton, United StatesAssociate Scientist, Bioanalytical Services · Exton, PA (Corporate) · Responsibilities · * Associate Scientist / Bioanalytical Services Essential Functions Provide support for running sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/PK assessment · * Coordin ...
-
Associate Lab Automation Scientist
2 weeks ago
J&J Family of Companies Malvern, United StatesAssociate Lab Automation Scientist W · **Description** · Johnson & Johnson is recruiting for an Associate Lab Automation Scientist located in Malvern, PA. · At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world w ...
-
Associate Scientist, Bioanalytical Services
1 week ago
Frontage Laboratories Exton, United StatesJob Description · Job DescriptionAssociate Scientist, Bioanalytical ServicesExton, PA (Corporate) · ResponsibilitiesAssociate Scientist / Bioanalytical Services Essential Functions Provide support for running sensitive, reliable and efficient LC-MS/MS bioanalytical assays for TK/ ...
-
Associate Scientist I/II
1 week ago
Alcami Corporation Wilmington, United StatesFree Healthcare Option | Bonus Program | 401(k) with Match | College Loan Forgiveness · Core Values: Trustworthy, Relentless, Accountable, Collaborative, Customer-Focused, and Skilled · At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines ...
Associate Scientist I - Newark, United States - QPS, LLC
Description
Job Description
Job DescriptionQPS, LLC is an innovative and dynamic Contract Research Organization (CRO) that has been assisting pharmaceutical, biotechnology, and medical device companies with their drug development efforts by providing a full range of GLP-compliant bioanalysis, DMPK, and protein/genomic biomarker services since 1995. Please visit our website ) for more information and to see all current openings.
Job Summary
Compliance with applicable regulatory guidelines and requirements is critical for our pharmaceutical clients, and our QA Auditors are key to ensuring that we meet these expectations. This junior-level role requires attention to detail, organization, multi-tasking, and comfort interacting with people who might be junior or senior to the incumbent.
Essential Functions
Knowledge/Skills/Abilities
Education/Experience
QPS, LLC is an Equal Employment Opportunity/Affirmative Action Employer. In accordance with federal, state, and local laws, we recruit, hire, promote and evaluate all personnel without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, citizenship status, physical disability, protected veteran status, or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability, experience, and the requirements of the job. In addition, QPS, LLC is a federal contractor and desires priority referrals of protected veterans.
