Quality Control Manager
The Quality Control Manager will support the QC operations and work in a laboratory under the direction of QC Director. The candidate will be involved in overseeing QC laboratory activities such as setting-up methods, validating and executing assays for analysis, stability studies, release of raw materials and biological products, as well as maintaining the laboratory in regulatory compliance. The position will involve working with PCR, Elisa, Gel electrophoresis, DNA/ RNA, DNA sequencing, endotoxin and sterility assays, in addition with chromatography/ spectroscopy instrumentation (e.g. HPLC, LC-MS/MS, high-throughput automated fluorescence systems), and variety of chemical/ micro-biological assays. The candidate will interact with R&D, production, quality and technical teams, as well as contract labs on analytical testing projects. This is a great opportunity for candidates considering a quality control career in biotechnology or the life sciences.
- Accountable and responsible for ensuring cGMP and safety compliance in Quality Control laboratory
- Oversee release testing, stability studies, methods optimization and validation, conducting method transfers and preparation of technical reports to ensure conformity to standards and specifications. Prioritize lab work and maintain project schedules
- Responsible for interacting with vendors regarding specifications of raw materials, and contract laboratories regarding testing of products
- Responsible for reviewing and approving quality control documents (notebooks; logbooks; raw material, stability and release files)
- Ensure QC activities are conducted in compliance with required FDA, Fire, OSHA, EPA, Sanitation and internal procedures. Ensure the staff is properly trained on QC procedures
- Perform assigned testing for analytical assays, validation and stability samples
- Work with bacteriophages and associated assays, such as, PCR, Elisa, gel electrophoresis, microbiological bioactivity assays and DNA sequencing,
- Operate, calibrate, troubleshoot and maintain analytical equipment. Assist in equipment validations (IQ, OQ, PQ, and MQ)
- Write Standard Operating Procedures (SOPs), analytical technical reports, method validation and stability protocols and reports. Conduct literature search to identify suitable methods. Maintain organized, accurate and complete laboratory notebooks and records
- Analyze problems, identify alternative solutions, and implement recommendations for resolution of problems.
- Process, analyze and organize large data sets
- Assist in general upkeep of laboratory and maintain a clean work environment.
Minimum & Preferred Qualifications:
- Must have a bachelor’s or graduate degree in Biochemistry, Microbiology, Biological Sciences, or related field
- Must have 5 years of GLP/cGMP bioanalytical laboratory experience in industry (biotech/pharma company)
- Knowledge and compliance to GLP/cGMP, pharmaceutical FDA/ICH/USP guidelines, laboratory documentation, safety and environmental requirements
- Experience utilizing microbiological, biochemical, spectroscopic and chromatographic analytical techniques. Working knowledge with biological products
- Able to troubleshoot and solve problems encountered with methods and instrumentation.
- Knowledge of FDA, Fire, OSHA, EPA and Sanitation procedures for the QC laboratory
- Experience with Microsoft Office products (proficiency with Excel) and working knowledge of chromatography and spectroscopy instrument software. Able to understand statistics and statistical software to interpret experimental results
- Advance level of written and verbal communication skills with ability to read technical procedures or governmental regulations and guidelines. Able to write reports, and required quality control documentation
- Time management skills to optimize the analysis process and multitask
- Must be reliable, detail oriented, and collaborative, with the ability to organize and prioritize tasks/projects
- Support quality and continuous improvement processes. Willing for continued education, training or certification in quality control laboratory skills for fulfilling the assigned duties, as necessary
- Excellent interpersonal and communication skills to effectively work within a team environment
- Self-starter and quick-learner. Ability to work under minimal supervision.
Send cover letter and CV to: email@example.com