QC Document Reviewer

Noven Pharmaceuticals; Miami (FL); On-site; USD 50,000 - 70,000; Full time

Job summary

A pharmaceutical company in Miami is looking for a QC Document Reviewer to carry out sample analysis and ensure compliance with quality standards. The ideal candidate will have a degree in chemistry or a related scientific field and experience with chromatographic analysis. Strong organizational and communication skills are essential. This full-time position requires a high level of detail and the ability to work under pressure in a laboratory environment.

Qualifications

• Minimum four years experience with a bachelor’s degree in chemistry required or equivalent experience.
• Broad knowledge in scientific methods and chromatographic analysis.
• Good written English and verbal communication skills.

Responsibilities

• Responsible for sample analysis and data processing.
• Review test results for compliance with GLP and internal SOPs.
• Compile and maintain review records according to best practices.

Skills

Chromatographic analysis

Analytical methods (HPLC, GC)

Wet chemistry techniques

Communication skills

Organizational skills

Interpersonal skills

Microsoft applications

Education

Bachelor’s degree in chemistry or related field

Master’s degree in chemistry or related field

PhD in chemistry or related field

Tools

Waters Corp. Empower

LIMS

Job description

Join to apply for the QC Document Reviewer role at Noven Pharmaceuticals

Responsibilities

• This individual will be responsible for carrying out sample analysis and data processing within stated timeframes and in accordance with Standard Operation Procedures (SOPs) and Company Policies.
• Perform detailed data review of test results from HPLC, GC, IC assays for compliance with GLP and internal SOPs to support laboratory operation.
• Review lab equipment calibration records, logbooks, and other review functions as needed.
• Compile and maintain review records in accordance with SOP's and QC best practices.
• Work with analysts to complete any corrections to data notebooks, LIMS, Empower, etc.
• Communicate and respond to inquiries from internal departments regarding the status of results.
• Prepare and review forms and SOPs as needed.
• May be required to assist in training personnel in review procedures.
• Assist in preparing internal departmental documents such as SOPs, training documents, methods, and study plans.
• Must always comply with the Laboratory Safety Policy.

Qualifications

• Minimum of four years of experience with a bachelor’s degree in chemistry or related scientific field required. Alternately, three to six years of experience with a master’s degree in chemistry or related scientific field. Alternately, zero to three years of experience with a PhD in chemistry or related scientific field -Required.
• Broad knowledge of scientific principles, methods, chromatographic analysis, analytical methods (i.e. HPLC, GC, Dissolution) and a good understanding of separation theories -Required.
• Candidate must have broad knowledge in all types of compendia testing (USP, EP, JP, BP) and wet chemistry techniques-Required.
• Good written English and verbal communication skills-Required.
• Must be highly organized and able to work under pressure.
• Must have strong interpersonal and leadership skills.
• Must have computer literate with knowledge in all Microsoft business applications.
• Strong background in scientific software such as Waters Corp. Empower and LIMS is a plus.
• Knowledge of GLP.
• Ability to multi-task and participate in multiple studies concurrently.
• Ability to produce high quality data while working under the pressure of strict deadlines.
• Work may require the use of PPE (personal protective equipment).

Judgment / Decision Making

Duties are performed under general direction toward broad assignments with periodic reviews. Duties are performed within the framework of departmental or functional guidelines, requiring interpretation and original thinking.

Work Environment

An office environment but on occasions could be work in a laboratory environment with exposure to chemicals, caustics, fumes, heat, and electrical current.

Physical Demands

Visual acuity and manual dexterity required to operate computer, analytical instrumentation, sample preparation and proofread documents. The majority of time spent sitting and walking. Often required to lift objects weighing up to 20 pounds.

Seniority level: Associate

Employment type: Full-time

Job function: Analyst, Quality Assurance, and Writing/Editing

Industries: Pharmaceutical Manufacturing