QC Specialist

Job Summary:

The Quality Control Specialist has primary responsibility for the final testing of finished product and in-coming raw materials using a variety of analytical techniques, confirming that specifications are met. The Quality Control Specialist has the authority to approve or reject products as necessary. Assists in the development, implementation, and maintenance of Quality Control procedures.

Responsibilities:

Role Specific Responsibilities:

Understands and complies with cGMPs and other regulations Performs wet analyses and physical testing of in-process, raw material, finished goods, and cGMP stability samples using documented standard techniques. Also performs analyses on side stream shipments and hazardous wastes. Identifies product defects or potential issues and reports to management Compiles and interprets results of tests and analysis Prepares laboratory reagents, standards, and mobile phases as instructed by quality management Reviews and signs laboratory notebooksResponsible for SAP data recording and material movements Leads and documents out of specification analytical test result investigations for GMP products Performs product statistical analysis as instructed by quality management Responsible for maintaining stockroom - includes safety labeling, addressing identified areas of concern from safety audits, purging out of date retains, etc. Performs other duties and completes special projects as assigned

Compliance:

Complies with company Health, Safety and Environmental policies, procedures, and arrangements Reports all Health, Safety and Environmental accidents, incidents and near misses promptly Acts in a safe and responsible manner at all times

Problem Solving and Innovation:

Active participation in continuous improvement activities Participates in problem-solving Takes responsibility and ownership for own learning and development in the spirit of continuous improvement of both self and the business Assists in the training, mentoring, and assessment of other team members Exercises autonomy and judgement subject to overall direction or guidance

Qualifications/Desired Skills:

Education and Qualifications:

Bachelor’s degree in Chemistry/Biology, or related science field required. Familiar with QC & QA functions

Experience:

5+ years of Quality Control/ Quality Assurance experience 5+ years of experience in a cGMP regulated environment

Knowledge, Skills, and Abilities:  

Ability to work in a team environment within a multi-functional, organizational structure and exhibits robust interpersonal skills  Excellent proficiency within Microsoft products (Outlook, Excel, Word, PowerPoint)  SAP knowledge is a plus  Critical thinking and conflict resolution skills and analytical abilities  Knowledge in wet chemistry techniques, titrations, GC, HPLC, NIR, IR, RI is a plus  Reliable and trustworthy in the highest ethical standards and integrity  Embodies the Aurorium CODE:  credible:  keeps their word and honors their commitments, acts with integrity, and holds themselves accountable to their decisions and actions outcome-oriented: adheres to an unparalleled standard of excellence in everything they do, to deliver results with real impact  driven: passionate about delivering authentic, world-class experiences that engage customers and inspire greatness empowered accountability: empowered to achieve common goals and accountable for delivering performances and results that exceed standards

 

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