The role requires flexibility for weekend coverage to support a continuous operational schedule. This is a first shift position Saturday-Tuesday (4 x 10 hours), but will require an initial period of Monday-Friday work to accommodate training.
Skills:
RAW MATERIALS TESTING
QC TESTING
LIMS
ENVIRONMENTAL MONITORING
GMP
Additional Skills:
MICROBIOLOGICAL
LABORATORY
ICH
WRITING SKILLS
EXCEL
LABWARE
CMC
DATA ANALYSIS
SOPS
OPERATIONS
TECHNICAL DOCUMENTATION
ORGANIZATIONAL SKILLS
MICROBIOLOGY
PROBLEM-SOLVING
PHARMACEUTICAL/BIOTECH
SAP
CHEMISTRY
MICROSOFT POWERPOINT
CORRECTIVE AND PREVENTIVE ACTION
Duties:
The Quality Control Operations (QCO) Analyst III Contractor plays a crucial role in supporting the department's efforts to maintain the highest standards of quality and compliance from development through to commercialization. In addition to executing routine and non-routine testing in support of development through commercial programs, the Analyst III will also participate in data trending, investigations, and laboratory operations. This position will also play a role in method transfers, method qualification/validation, verification, and implementation. By ensuring these critical activities are executed with precision, the Analyst III significantly contributes to routine laboratory operations, thereby enhancing the overall efficiency and effectiveness of the QC functions.
Key Responsibilities (including but not limited to):
Perform routine and non-routine analytical and/or microbiological assays to support raw materials, in-process samples, product release, and stability studies, following established SOPs
Support a continuous operational schedule by supporting weekend laboratory operations (Analytical, Microbiology, Raw Materials).
Maintain up-to-date training records, adhere to the testing schedule, and ensure the timely completion of all assignments to support the seamless operation of QC activities and uphold the department's commitment to meeting project timelines and quality metrics
Assist in the maintenance of laboratory equipment and inventory, including the preparation of reagents and samples to ensure smooth laboratory operations
Ensure data are reviewed timely; qualify as a data reviewer to ensure timely and efficient data availability.
Perform role-specific operational assignments (e.g., raw material processes including SAP transactions, environmental monitoring, in-process testing, etc.).
Contribute to the revision and updating of controlled documents, including SOPs, work instructions, and test methods, to ensure continuous improvement and compliance with current industry standards and regulatory requirements
Adhere to internal standards, policies, and SOPs, as well as regulatory and industry standards (e.g., GMP, GLP, ICH guidelines) to maintain the highest levels of quality and compliance.
Actively participate in continuous improvement efforts by identifying and suggesting enhancements to methods and laboratory processes, particularly those related to efficiency and reliability.
Collaborate with QC and cross-functional teams to ensure seamless quality control operations and to support the collective companies goals
Pursue ongoing training and development to deepen expertise in QC testing techniques, TOQ operations, and regulatory compliance.
May assist in preparing technical documentation for regulatory submissions by performing data verification, ensuring accuracy and compliance with regulatory standards.
Participate in inspection readiness activities as well as supporting onsite audits and inspections, as needed.
Actively participate in continuous improvement initiatives aimed at enhancing QC processes and procedures, increasing laboratory efficiency and effectiveness.
Collaborate with other organizational functions including CMC Development, Manufacturing, Manufacturing Technical Services, Materials Management, and Quality Assurance to ensure alignment with overall business goals.
Skills:
B.S. in chemistry, biology, or biochemistry, or related scientific field;
Education:
Pharmaceutical/Biotech industry experience with 4 years in a GMP Quality Control function or equivalent, relevant industry experience
Experience in method transfer and/or analytical method implementation; solid understanding of method lifecycle management and phase-appropriate approach is desirable
Demonstrated technical writing skills, with preference for technical writing of investigations
Proficient in data analysis and interpretation, with excellent attention to detail to inform decision-making
Solid problem-solving skills and experience in conducting investigations and implementing CAPA
Strong organizational skills with the ability to manage multiple tasks simultaneously and autonomously
Excellent communication and teamwork abilities, capable of working effectively in a collaborative environment
Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred
Minimum Degree Required:
Bachelor's Degree
Certifications & Licenses:
CAPA
Proficiency in LabWare LIMS, Excel, Word, and PowerPoint preferred