Quality Control Analyst I

Quality Control Analyst I - 3rd Shift

The Quality Control Analyst I is responsible for performing routine and non-routine analytical chemistry assays of raw materials, in-process samples, finished APIs, and stability samples. This role also participates in special projects, method development/transfers and cleaning study qualifications.

Supervisory Duties

This position does not have supervisory responsibilities.

Essential job duties

Perform analytical testing for incoming, in-process and final products, and stability samples using equipment such as balances, pipettes, pH meter, UV/Visible spectrophotometer, Total Organic Carbon analyzer, etc.

Perform chromatography (Liquid/GC) after extensive qualification and training

Perform wet chemistry assays

Regularly perform water sample collection

Back up for QC analytical instrument maintenance and calibration

Performance of QC general laboratory equipment maintenance, laboratory housekeeping and preparation of the laboratory for audits

Assist in the review of QC data and provide summaries to management as needed

Assist QC Management, as needed, in the completion of OOS, deviations and CAPAs investigations for QC

Backup for QC analytical sample receipt for internal testing, outside laboratory testing, login, processing, shipment, tracking, distribution of test results, and closure

Qualifications:
Required

Bachelor’s degree in Chemistry or related field

Minimum 0-3 years’ pharmaceutical experience or equivalent combination of education and relevant experience

Preferred

Experience in a cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities

Excellent verbal and written communication skills, including the ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public

Ability to meet deadlines and work under pressure with limited supervision

Strong time management and organizational skills with the ability to multi-task and manage multiple projects independently

Ability to read, analyze, and interpret, professional journals, technical procedures, or governmental regulations

Ability to write reports, business correspondence, and procedure manuals

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations

Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis

Ability to define problems, collect data, establish facts, and draw valid conclusions

Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

Proficient use of computer software, including Microsoft Office Suite and instrument manufacture-based systems

Knowledgeable in FDA GMPs (21 CFR, 211, 820, and/or 600); ISO 9001 and 13485 a plus

Physical requirements

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 may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to stand; walk; or sit; use hands to finger, handle, or feel; and talk or hear. The employee frequently is required to reach with hands and arms. The employee is often required to climb or balance; and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, and ability to adjust focus.

The above statements are intended to describe the general nature and level of work performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all job duties performed by the personnel as classified. Management reserves the right to revise or amend duties at any time.

All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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