TITLE: Quality Assurance/Quality Control Specialist
REPORTING TO: Senior Scientist, HIV & AIDS Program
LOCATION: Center for Biomedical Research, New York, NY
JOBS SUPERVISED: N/A
ASSIGNMENT LENGTH: Eighteen months, renewable by mutual consent and availability of funding
A STRONG CANDIDATE HAS BEEN IDENTIFIED FOR THIS ROLE
POSITION SUMMARY: The candidate will support the Microbicide Product Development Group in all activities involving SOP writing, quality assurance, and compliance with applicable regulatory requirements including quality control (QC) activities for research & development and good manufacturing practice (GMP) manufacturing operations.
1. Write, revise, and organize SOPs and other documents for the Microbicides Lab by collecting information from internal stakeholders, drafting and circulating documents for review, completing a final version for submission to Regulatory Affairs, and managing the Lab's SOP tracking sheet.
2. Approve internally generated documents and laboratory notebooks by reviewing documents and notebooks for accuracy of calculations and conclusions, completeness, proper format and content, required signatures, and adherence to GMP guidelines.
3. Oversee label and packaging control for GMP synthesis by maintaining inventory of labels, overseeing packaging of drug products into primary and secondary containers, and verifying shipments are sent according to prearranged specifications.
4. Develop and manage document management system for Microbicides Lab by creating and maintaining control over an online system that will allow users to gain rapid access to all lab documents in the event of internal or external audits or requests for information.
1. Bachelor’s Degree
2. Minimum 5 years of SOP writing experience and familiarity with GMP, QA, and QC activities
3. High proficiency in Microsoft Office, with a particular focus on Microsoft Excel and Word.
4. Strong writing and organizational skills, attention to detail and follow-through, and ability to multitask.
5. Excellent interpersonal skills.
The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of country offices. We are seeking an individual to fill the position described. If you know of a qualified candidate or are interested in this position, please apply at: http://www.popcouncil.org/employment/index.asp .
The Population Council provides equal opportunity; it does not discriminate against any person with regard to age, color, creed, national origin, disability, political belief, veteran status, religion, marital status, gender, gender identity, or sexual orientation. Decisions on employment are based on an individual’s qualifications as related to the position for which s/he is being considered. The Council especially encourages applications from qualified women and members of minority groups. The Population Council is international in the composition of its board of trustees and its staff, as well as in the nature and deployment of its activities.