QC Review Specialist - 1st Shift

Review lab documentation and procedures to ensure compliance.

• Ensures samples are sent to the appropriate contract labs with applicable documentation.
• Tracks contract lab testing from samples sent out to data report, including electronic storage of reports.
• Performs detailed data review of analytical test results generated by contract testing labs to assure correctness and accuracy.
• Performs detailed review of basic analytical test results generated by the QC department for compliance with cGMP, internal SOPs, and specifications to support production, stability studies, method development, and QA, R&D, and lab operations.
• Utilizes product safety review and material qualification for data review and disposition.
• Provides information for investigative steps of laboratory non-conformance 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.
• Maintains metrics of reviewed data, analyst training, errors, investigations, etc.
• Initiates and participates in process improvement activities.
• Completes 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.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations will be made to enable individuals with disabilities to perform essential functions.

(Other combinations of education/experience would be considered based on business need)

• Bachelor's degree (B.S.) or equivalent from a four-year College or technical school in a laboratory science such as Chemistry, Biology, or a related field.
• Minimum of one year of experience in laboratory and/or QA/Regulatory compliance.
• Advanced computer skills, including Microsoft Word and Excel, are required.
• Experience with database management systems such as Oracle, LIMS, and Epicor desired.
• Knowledge of industry quality control procedures, standard operating procedures, and compliance experience are required.
• At least one year of experience with general laboratory procedures, instrumentation, and analytical instrumentation experience preferred.
• Strong working knowledge and application of cGMP regulations.

• Ability to read and interpret documents such as analytical data, product specifications, departmental instructions, and procedure manuals.
• Ability to communicate and work with peers and management transparently and professionally.

• Ability to apply concepts such as fractions, percentages, averages, ratios, proportions, and the metric system to practical situations.

Entry-level technical skill set:

• Ability to compare primary test results to specifications to…