Quality Control Analyst II

Job Description
Quality Control Analyst II

Location: Rensselaer, NY

Shift: This role is an overnight 12-hour rotating shift position .

Our client is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients.


Requirements

Position overview

The Quality Control Analyst II 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.

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.

Essential job duties

1. Perform analytical testing for incoming,in-process and final products, and stability samples using equipment suchas balances, pipettes, pH meter, UV/Visible spectrophotometer, TotalOrganic Carbon analyzer, etc.
2. Perform chromatography (HPLC/GC, UPLC) withminimal qualification and training, wet chemistry assays, analyticalchemistry assays, HPLC, GC, IR, UV, etc. and raw material testing and/orsampling
3. Back up for QC analytical instrumentmaintenance and calibration
4. Perform QC general laboratory equipmentmaintenance, laboratory housekeeping and preparation of the laboratory foraudits
5. Perform or assist with QC methodqualifications, transfers and validations
6. Perform QC method development
7. Perform OOS investigations and lab deviationinvestigations
8. Provide technical support for shiftanalysts
9. Perform cleaning validation studies
10. Assist with the evaluation of new equipmentand processes
11. Assist in the review of QC data and providesummaries to management as needed
12. Assist QC Management, as needed, in thecompletion of OOS, deviations, and CAPAs investigations for QC
13. Backup for QC analytical sample receipt forinternal testing, outside laboratory testing, login, processing, shipment,tracking, distribution of test results, and closure

Education, experience, certification and licensures Required
•Bachelor's degree in Chemistry or related field
•Minimum 3-5 years' experience in pharmaceutical industry environment or equivalent combination of education and experience

Preferred
•Experience working in cGMP or GLP pharmaceutical industry environment

Knowledge, skills and abilities

1. Excellent verbal and written communicationskills, including the ability to effectively present information andrespond to questions from groups of managers, clients, customers, and thegeneral public
2. Ability to meet deadlines and work underpressure with limited supervision
3. Strong time management and organizationalskills with the ability to multi-task and manage multiple projectsindependently
4. Ability to read, analyze, and interpretgeneral business periodicals, professional journals, technical procedures,or governmental regulations
5. Ability to write reports, businesscorrespondence, and procedure manuals
6. Ability to apply advanced mathematicalconcepts such as exponents, logarithms, quadratic equations, andpermutations
7. Ability to apply mathematical operations tosuch tasks as frequency distribution, determination of test reliabilityand validity, analysis of variance, correlation techniques, samplingtheory, and factor analysis
8. Ability to define problems, collect data,establish facts, and draw valid conclusions
9. Ability to interpret an extensive variety oftechnical instructions in mathematical or diagram form and deal withseveral abstract and concrete variables
10. Proficient use of computer software,including Microsoft Office Suite and instrument manufacture-based systems
11. Knowledgeable in FDA GMPs (21 CFR, 211, 820,and/or 600); ISO 9001 and 13485 a plus

Our client proudly offers

• Generous benefit options (eligible first dayof employment)
• Paid training, vacation and holidays(vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

Physical requirements

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. 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 occasionally 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.

Work environment

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee has the potential of being exposed to fumes or airborne particles and toxic or caustic chemicals (wearing proper Personal Protective Equipment will be required in these situations). The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; outside weather conditions; and risk of electrical shock (always being aware of one's environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee will be responsible for generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the Resources, Conservation and Recovery Act. Employee will understand waste labeling, secondary containment, chemical compatibility, storage time limits, container size and quantity limits, container integrity when waste is left unattended and improper disposal of hazardous materials.

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.

Pay Range :$63,000 - $79,000

All interested applicants must apply online. Please be aware of scammers. Our client will only send offer letters and requests for sensitive personal information from a company email address. Our client 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. Our client is an E-Verify employer.