Description
**Job Summary:** QC CAS – Sr Associate
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing of Commercial, Stability, Utilities, raw materials and Validation.
+ Contributes to team by ensuring the quality of the tasks/services provided by self
+ Contributes to the completion of Milestones associated with specific projects or activities within team
+ Strives to complete activities right first time
Extended hours and weekend work flexibility may be necessary as required.
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**Specific Job Duties:**
+ Plan and perform analyses with great efficiency and accuracy.
+ Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
+ Report, evaluate, back-up/archive, trend and approve analytical data.
+ Troubleshoot, solve problems and communicate with stakeholders.
+ Initiate and/or implement changes in controlled documents.
+ Participate in audits, initiatives and projects that may be departmental or organizational in scope.
+ Review protocols and perform assay validation and equipment qualification/ verifications when required.
+ Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
+ May contribute to regulatory filings.
+ May conduct lab investigations as necessary.
+ Evaluate lab practices for compliance on a continuous basis.
+ Approve lab results.
+ May interact with outside resources.
+ LIMS data coordination of commercial and import testing on site where applicable
+ May represent the department/organization on various teams.
+ May train others.
**Primary Knowledge, Skills, Competencies and Relevant Experience**
**Knowledge:**
+ Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure & continuous learning
+ Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
**Skills:**
+ Communication skills (verbal and written) at all levels
+ Strong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
+ Presentation skills
+ Escalate issues professionally and on a timely basis
+ Decision Making skills
+ Teamwork and Coaching others
+ Negotiation and Influence skills
+ Investigation skills
+ Problem solving skills. Applies research, information gathering, analytical, and interpretation skills to problems of diverse scope
+ Ensures compliance within regulatory environment
+ Develops solutions to technical problems of moderate complexity
+ Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
+ Interprets generally defined practices and methods
+ Able to use statistical analysis tools to perform data trending and evaluation
+ Project Management and organizational skills, including ability to follow assignments through to completion
**Competencies:**
+ Demonstrated ability to work independently and deliver right first time results
+ Works under minimal direction Work is guided by objectives of the department or assignment
+ Follows procedures
+ Refers to technical standards, principles, theories and precedents as needed
+ May set project timeframes and priorities based on project objectives and ongoing assignments
+ Recognizes and escalates problems
+ Working knowledge of aseptic compliance within the manufacturing environment and demonstrated leadership and communication skills to communicate requirements to colleagues
+ Auditing documentation and operation process
+ Demonstrated ability to interact with regulatory agencies
**Relevant experience:**
+ Bachelor’s degree in a Science related field is required.
+ 4+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry,
+ Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.
