QUALITY SPECIALIST OpGen
THIS JOB HAS EXPIRED OpGen, Inc. is a leading innovator in rapid, accurate genomic and DNA analysis systems and services. The company has developed a platform, The Argus Whole Genome Mapping System and also offers MapIt? Services that provide high resolution, whole genome restriction maps for sequence assembly and finishing, strain typing and comparative genomics in the life sciences market. This proprietary de novo technology is free from the limitations of gel, PCR and sequencing-based methodologies, and expansion of Whole Genome Mapping technologies to large genomes and clinical diagnostics is currently in development. OpGen?s customers include leading genomic research centers, biodefense organizations, leading genomic research centers, academic institutions, clinical research organizations and biotechnology companies.
OpGen is committed to supporting our Customers as valued partners by creating long-term relationships and continually exceeding their expectations. OpGen employees have created the company?s success. As a result of that success, we are seeking individuals who enjoy a challenge and desire to be part of a team making a difference in healthcare outcomes.
This position will be the lead position in Manufacturing Quality Assurance that will be responsible for compliance to cGMP within Operations. The scope of the position will also include Document Control activities such as processing new documentation, revising existing documentation and managing the document control system. This position will also serve as backup for testing and release of product during periods of high production activity.
Primary Job Functions
Insure that all activities performed within Operations are performed in a manner consistent with cGMP requirements.
Conduct audits of practices within operations to insure compliance with cGMP requirements.
Conduct training sessions on cGMP principles and guidelines.
Conduct audits of equipment and facilities used in the manufacturing and testing of product to insure fitness for use. Insure calibration of equipment used in the manufacture and testing of product is current.
Monitor temperature of refrigerators, freezers and controlled work areas to insure spec limits are being maintained.
Monitor water quality on a daily basis and test weekly to insure specs are being maintained.
Manage the Document Control system to insure that only current, approved documents are used in the manufacture and testing of product. Manage the Change Control process for existing documents and insure that all issues are addressed in a timely manner and that all signatures are obtained in a timely manner. Modify existing documents and create new documents as required.
Review all documentation, including Batch Records for accuracy and completeness prior to filing. Control the storage of batch records to insure that completed records are not misplaced.
Work with Product Support on monitoring customer complaints and identifying when corrective actions are required. Similarly monitor practices within Operations and identify when corrective actions are required to improve control. Issue CAR?s and CAPA?s as required to address improvements needed and track through to completion.
Back up QC testing as required in analytical testing on reagents, functional testing on components and kits, inspection and testing of incoming materials and the like.
BS/BA degree in chemistry, biochemistry, molecular biology or a related discipline preferred. 4 yr college degree, preferably in Science, required. At least 3 yrs experience in performing QA activities in an FDA regulated environment required. Experience in leading QA activities is highly desirable. Work experience must show an emphasis on the QA function and a proclivity to continue in a QA role.
Must be thoroughly knowledgeable in cGMP requirements. Experience in training others in cGMP principles is highly desirable.
Must be proficient in QA roles and responsibilities and able to carry out those responsibilities independently. Work history must demonstrate experience in successfully carry out the responsibilities of the QA function.
Work experience must demonstrate knowledge of QA responsibilities and the ability to lead the QA function.
Must have experience in auditing for GMP compliance and the ability to train others in GMP compliance.
Document processing and managing the document control system is a significant part of the responsibilities of this position.
Candidate must be accurate and attentive to details in their work. This position will be responsible for final and timely review of documentation and release of product.
Familiarity with the use of Excel and graphical analysis for trending is highly desirable.
Proficient in the use of Word-processing software packages required. Experience in the use of Excel and PowerPoint desirable.
Excellent communication and presentation skills required for training and reporting purposes.
Ability to interact effectively with personnel at all levels, particularly in problematic situations.
Ability to run analytical and functional assays, collect and interpret data, required.
This position will be required to make decisions based on documentation provided that will ultimately determine whether product will Pass or Fail. These decisions will have direct impact on the manufacturing activities of the company.
||GAITHERSBURG, MD |
THIS JOB HAS EXPIRED