Qc Review Specialist II

NOW Health Group•Bloomingdale, IL

47d•Onsite

About The Position

Performs detailed review of analytical and ICP test results generated by QC department for compliance with cGMP, internal SOPs and specifications to support production, stability studies, method development, QA, R&D and lab operation. Performs detailed data review for analytical test results generated by contract testing labs to assure correctness and accuracy. Coordinates with Method Development and/or Lab Management for resolution of any deviations from methods, discrepancies with specifications. Reviews data and reports associated with method transfers and method validation. Coordinates with multiple departments to obtain information for accurate sample review, such as product safety review and material qualification. Provides information for investigative steps of laboratory non-conformances investigations and escalates any issues noted to management. Communicates with management for timely resolution of invalid or problematic testing. Performs and/or facilitates SOP review, revising and training. Creates and/or reviews procedural SOP. Initiates change process for any erroneous methods or specifications. Updates spreadsheets to reflect status of reviewed data and metrics of errors, investigations and invalid runs; communicates status of priority runs in a timely manner. Initiates and participates in process improvement activities. Any special projects assigned by management. Complies with all safety and GMP requirements. Supports a culture of safe laboratory and production operations; follows all safety rules and procedures. Actively participates in the safety program by: engaging in training activities to learn what constitutes a safety hazard; reporting safety concerns to management or safety teams, submitting safety suggestions, and correcting or reporting to the appropriate people when the employee sees a workplace health or safety hazard, until it is resolved. Assists with communicating safety information to new employees. Fulfills responsibilities as outlined in the company safety management plan.

Requirements

Bachelor's degree (B.S.) or equivalent from four-year College or technical school in a laboratory science such as Chemistry, Biology or related field.
At least four years of laboratory and/or QA/Regulatory compliance experience.
At least two year of instrumentation troubleshooting and/or training experience.
At least two years of data acquisition, interpretation and/or reporting experience.
Excellent computer skills required, including Microsoft Word, Access and Excel.
Strong working knowledge and application of cGMP regulations.
Must be able to read and interpret documents such as complex analytical data, product specifications, departmental instructions, and procedure manuals.
Must be able to communicate and work with peers and management in a transparent and professional manner.
Ability to apply concepts such as fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.
Must be able to compare results obtained to specifications to determine if result meets requirements.
Must be able to gather, generate and interpret data and a variety of instructions.
Knowledge of industry quality control procedures, chemical laboratory instrumentation, standard operating procedures and compliance experience required.
Excellent time management, meeting deadlines, attention to detail, verbal and written communication skills, listening, decision-making, troubleshooting/problem solving and organization skills required.
Must be a self-starter and able to handle multiple tasks.

Nice To Haves

Experience with database management systems such as Oracle and LIMS are desired.

Responsibilities

Performs detailed review of analytical and ICP test results generated by QC department for compliance with cGMP, internal SOPs and specifications to support production, stability studies, method development, QA, R&D and lab operation.
Performs detailed data review for analytical test results generated by contract testing labs to assure correctness and accuracy.
Coordinates with Method Development and/or Lab Management for resolution of any deviations from methods, discrepancies with specifications.
Reviews data and reports associated with method transfers and method validation.
Coordinates with multiple departments to obtain information for accurate sample review, such as product safety review and material qualification.
Provides information for investigative steps of laboratory non-conformances investigations and escalates any issues noted to management.
Communicates with management for timely resolution of invalid or problematic testing.
Performs and/or facilitates SOP review, revising and training.
Creates and/or reviews procedural SOP.
Initiates change process for any erroneous methods or specifications.
Updates spreadsheets to reflect status of reviewed data and metrics of errors, investigations and invalid runs; communicates status of priority runs in a timely manner.
Initiates and participates in process improvement activities.
Complies with all safety and GMP requirements.
Supports a culture of safe laboratory and production operations; follows all safety rules and procedures.
Actively participates in the safety program by: engaging in training activities to learn what constitutes a safety hazard; reporting safety concerns to management or safety teams, submitting safety suggestions, and correcting or reporting to the appropriate people when the employee sees a workplace health or safety hazard, until it is resolved.
Assists with communicating safety information to new employees.
Fulfills responsibilities as outlined in the company safety management plan.