This site uses cookies. To find out more, see our Cookies Policy

QA Associate II (QA, GLP, Batch Records, cGMP, CAPA, Change Control) in Princeton, NJ at Apex Life Sciences

Date Posted: 12/7/2018

Job Snapshot

Job Description


QA Associate/Data Reviewer

JOB SUMMARY/OBJECTIVE:

Biopharmaceuticals Quality Assurance Associate performing a wide variety of  activities pertaining to assuring quality compliance in adherence with applicable Regulatory requirements and corporate quality (QA) policies by coordinating training programs, conducting audits, data and documentation reviews and supporting site investigations. The QA position will maintain the Quality Standards of the company’s products or services by ensuring adherence to company policies, Regulatory guidance and client specific requirements.  This QA Data, compliance, documentation support role will interface with Quality and Research personnel.  This GLP/GDP position will be responsible for assisting in internal audits. 

ESSENTIAL JOB FUNCTIONS:

  • Perform reviews of data/reports associated with GMP QC testing (release, in-process and stability) and research data/reports that support potential customer filings.
  • Participates in root cause analysis for site incident investigations, and the development of CAPAs, Change Control documentation, technical memos, Regulatory documents and commitments.
  • Support site training initiatives by participating in New Employee orientation activities, including training employees on general GDP and Data Integrity skills, coordinating training of site employees as required, and creating and submitting periodic reports to management including quality metrics.
  • Perform Documentation Coordinator activities to provide assurance that SOPs, Test Methods, Specifications and COAs are reviewed, approved and archived in a timely manner
  • Support Quality and Research Management with issues of compliance to established Company policies, Regulatory guidance (cGMP) and client specific requirements. 
  • Participates in special projects as assigned.
  • Identify potential compliance issues and opportunities for improvement to the product disposition system.  Assist in the implementation of process changes to enhance compliance and improve method and product development process.
  • Execute Data Integrity initiatives throughout the facility in coordination with the DI lead

POSITION REQUIREMENTS:

  • Must be independent and have knowledge in GMP Quality Control data review or Batch Record review for Early and Last Stage Development.
  • Team player with the ability to work collaboratively with other functions gaining their cooperation in dealing with issues of compliance.
  • Rational persuasion particularly in the discussion with manufacturing.
  • Extremely high attention to detail and concerns to standards are required.
  • Critical thinking with the ability to read, analyze and interpret technical data.
  • Deductive reasoning with the ability to deal with abstract and concrete variables in situations where only limited standardization exists.

EDUCATION AND QUALIFICATIONS:

  • B.S. /B.A.in science related field, and familiar with biopharmaceuticals, GLP, cGMP, GMP, Technical writing, CAPAs, regulations and guidelines for audits, investigations and scientific data analysis.
  • Minimum of 1 years’ experience in a decision making Quality (QA) scientific role.
  • Knowledge of Success Factors and Continuous Improvement skills (PPI) is desirable.
  • Ability to apply GMP or GLP Regulations and other international guidelines to all aspects of the position.
  • Technical writing skills.
  • Technical knowledge of Biopharmaceutical Up/Downstream manufacturing and/or method development is desirable.

Please send your resume to Teleca Ogele at togele@apexlifesciences.com

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178.




884458