Quality - IQC Bulk Coordinator
: Job Details :

Essential Functions:

Release of incoming Bulk using internal or customer specifications and standards and other departmental reports.

Able to interacts with customers to obtain the necessary documentation and or standards to perform the testing / approval process.

Retain completed inspection report, standard and other inspections tools organized when needed or upon audit.

Performs Color, Odor and Appearance testing of oil & bulk materials as per SOPs and standards.

Prepare quality assurance documents related to inspection of materials.

Prepare bulk samples and submission forms to any outside service Laboratory for testing.

Conduct batch record reviews.

Interacts with manager and all levels of quality, planning and manufacturing and provide support on any bulk related aspects.

Follows good documentation practices.

Assist writing/reviewing job relevant SOPs for updates.

Maintain QA files and signed standards as required by GMPs and company rules.

Investigate customer complaints; investigate and suggest corrective actions to help develop strategy for change on an as needed basis.

Prepares and issues Non-Conformance reports as needed.

Assist with Quality audits and report findings; suggest corrective actions and follow-ups.

Plans resample and testing activities using the open order report and production schedule as required.

Coordinate sample collection and submission to the client representative.

Provide support to the R&D Lab with Bulk evaluations and blending process.

Trained to enter to customer portals (SAP/ Veeva, etc.) as part of the bulk approval process.

Evaluate and approved outside 3rd party work in process / finished goods . (Discover / Sniff and Scratch)

Computer basic skills.

Other duties as assigned.

Education/Experience:

Associates degree in a scientific discipline or 1 year certificate from college or technical school; or 1-2 years related experience and/or training or equivalent combination of education and experience.

Able to read, analyze and interpret common scientific/technical journals, safety rules, operating and maintenance instructions and procedure manuals. Able to write reports, correspondence and procedure manuals. Able to effectively present information and respond to questions from groups of managers, clients, customers.

Able to add, subtract, multiply and divide in all units of measure, using whole numbers, common fractions and decimals. Able to compute rate, ratio and percent and to draw an interpret bar graphs.

Able to define problems, collect data, establish facts and draw valid conclusions. Able to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Familiarity with ISO, cGMP and FDA requirements and Certificate of Training a plus