The Quality Control Operations (QCO) Analyst II Contractor supports maintaining high standards of quality and compliance from development through commercialization. The role includes performing routine and non-routine testing, participating in data trending, investigations, and lab operations, and supporting method transfers, qualification/validation, verification, and implementation. This position enhances QC efficiency and effectiveness.
Key Responsibilities:
- Perform routine/non-routine analytical (HPLC/UPLC) and/or microbiological assays for raw materials, in-process samples, product release, and stability studies following SOPs.
- Support weekend lab operations and maintain training records.
- Assist in lab equipment and inventory maintenance, including reagent and sample prep.
- Review data timely and qualify as a data reviewer Perform operational assignments (raw material processes, environmental monitoring, in-process testing).
- Contribute to updating controlled documents (SOPs, work instructions, test methods).
- Follow internal policies, SOPs, and regulatory standards (GMP, GLP, ICH) Participate in continuous improvement initiatives and cross-functional collaboration.
- Support regulatory submissions, inspection readiness, and audits.
Requirements
- B.S. in chemistry, biology, biochemistry, or related field 4-8 years of pharmaceutical/biotech experience in GMP QC or equivalent.
- Experience in method transfer/implementation; understanding of method lifecycle management.
- Strong technical writing, data analysis, problem-solving, and organizational skills.
- Proficiency in LabWare LIMS, Excel, Word, and PowerPoint.
Benefits
- Contract position with possible extension
- Location: Norton, MA, with occasional responsibilities at other locations.
- Weekend coverage is required.
- First shift, Friday-Monday (4 x 10 hours), with initial Monday-Friday training.
Skills Required
- Bachelor of Science degree in chemistry, biology, biochemistry, or a related field
- 4-8 years of pharmaceutical or biotechnology experience in GMP quality control or equivalent
- Experience with method transfer and implementation
- Understanding of method lifecycle management
- Strong technical writing skills
- Data analysis skills
- Problem-solving skills
- Organizational skills
- Proficiency in LabWare LIMS, Excel, Word, and PowerPoint
What We Do
BioPharma Consulting JAD Group provides a complete portfolio of technical support and solutions for the FDA regulated industry. We deliver solutions with a flexible cost effective approach to meet your company’s needs. BPC JAD group is a company created to help our customers bridge the gap between their business strategy and results. Our mission is to help our clients succeed by partnering with them and providing value added business solutions on the validation, engineering and compliance fields. We will carry out our mission by creating a long-term partnership with our customers and provide reliable and cost effective technical solutions. BPC JAD Group objective is to deliver reliable tailored solutions; from providing consultation to becoming part of your staff. We will develop customized frameworks to help our customers unlock the hidden value in their plants, facilities, equipment and people with an optimal integration of resources regulations and technology.
