QA Associate II - Operations (Wed-Sat 6:00 AM - 4:30 PM)
- Expired: August 28, 2021. Applications are no longer accepted.
Thrive in the dynamic and challenging environment of a contract development and manufacturing organization. Driven to excel through self-leadership and thriving team engagement. If this describes you, then look no further than LSNE.
We have the experience, expertise and a successful track record in completing development of life-changing pharmaceuticals and medical devices. Together with our clients, we work to bring about treatment of many forms of cancers, Diabetes, communicable diseases, and many other illnesses. Come make a difference.
Your work will matter and your contributions will be significant in these endeavors.We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!JOB SUMMARYThe Quality Associate II - Operations is responsible to provide QA support real-time for GMP Manufacturing of drug product. Responsibilities include providing QA on the Floor oversight of manufacturing including observing critical...
processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed. Real time continuous monitoring of manufacturing related systems and processes to ensure compliance with applicable regulatory and industry standards, needed quality improvements, and safety/efficacy for phase appropriate GMP manufacture of drug products.QUALITY ASSOCIATE ll- OPERATIONS JOB DUTIES Performs QA On-the-Floor activities supporting client projects, including room release, auditing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices Review executed Manufacturing Batch Records and supporting documentation for completeness, accuracy and compliance Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product Act as first responder for on the floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions May participate in root cause analysis using methodologies, such as: fishbone, 5 whys, etc. Act as QA reviewer for deviations and CAPA issuance; with limited approval authority as designated by QA Management Perform Acceptable Quality Limit (AQL) visual inspection of drug product Participate in SOP revision as it pertains to process improvements Participate in site quality and process improvement initiatives.
Represent QA on project teams and represent QA perspective as necessary Guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practicesPROFESSIONAL SKILLS Exceptional organizational skills and attention to detail Ability to make risk based decisions and resolve issues with minimal guidance Excellent interpersonal skills and the ability to communicate well orally and in writing Proficiency in MS Office including Word, and Excel Excellent verbal and written communication skills requiredEXPERIENCE Exposure to RCA, technical writing, and working with quality related investigations Exposure to lean operation excellence highly desirable Knowledge of FDA regulations (i.e., 21CFR Part 210, 211 & 820) and some experience working with international regulations such as ICH Knowledge and ability to apply basic scientific principles to solve operational, as well as routine quality tasks Experience using Risk Management Tools (FMEA, HACCP, PHA, etc.) and familiarity with ICH Q9 preferredEDUCATION Bachelor's Degree in a relevant scientific discipline preferred with a minimum of 2-3 years of pharmaceutical or biotech industry experience with 1+ years of experience in a QA Operations role supporting late stage clinical and/or commercial production ASQ certification preferredQUALITIES Ability to work in a dynam
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