Senior Quality Assurance Specialist

Senior Quality Assurance Specialist (Analytical)
Rensselaer, NY

Curia provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients' lives with the pharmaceuticals we develop and manufacture. 

We proudly offer:

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

Position overview:

The Senior Quality Assurance (QA) Specialist is responsible for the review of various documents, protocols, qualifications and/or reports related to Quality Management Systems. This role interacts with clients for quality related issues, as required. The Senior QA Specialist may be asked to participate in regulatory inspections, client audits and internal audits.

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.

Supervisory responsibilities:

This position does have supervisory responsibilities.

Responsibilities:

• Work cross-functionally with other departments on Quality Assurance activities such as reviewing various documents related to Quality control, QC related protocols, qualifications/validations and/or events related to Quality Management Systems
• Closely work with QC team in investigating the Out-of-Specification investigations and effective CAPAs in reducing the occurrences 
• Lead for QC compliance and ensure the QC is audit ready 
• Sound knowledge on Data integrity standards of QC systems - Audit Trail reviews 
• Participate in client audits and regulatory inspections
• Should be knowledgeable QC data review and Audit Trails, Good laboratory practices on integration, method parameters 
• Assist in the compilation of Curia documentation, systems and controls to ensure inspection-ready quality systems (e.g., ISO, FDA, QP, EMEA) for domestic and international inspections and registrations
• Maintain weekly and monthly metrics for the site
•  Review of specification, Test methods and changes to the approved specifications and test methods 
• Review the stability data, and review/approve stability reports 
• Identify continuous improvement efforts to build quality in all aspects of the process while considering cGMP/quality compliance
• Coordinate and/or perform day to day activities in conjunction with QA management and provide support to QA Specialists to ensure client timelines are on schedule and attainable

Qualifications:

• Bachelor's degree in Life Science or related field; alternate fields of study may be considered in combination with significant Aseptic/Microbiological industry experience
• Must have working experience in QC - experience working with chromatographic techniques is preferable
• Should have prior experience working with commercial QC, leading the QC OOS investigations
• Minimum 5-8 years' experience in an FDA-regulated pharmaceutical, biotechnology and/or medical device industry experience, including 5 years' GMP and/or QC or QA experience

Knowledge, skills and abilities:

• Working knowledge of Microsoft Office or other software as needed
• Excellent written and verbal presentation and communication skills
• Strong problem-solving skills, with the ability to resolve conflict
• Ability to effectively present information and respond to questions from clients, managers, and/or peers
• Comfortable working independently in combination with individuals in other departments across the organization to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• High degree of initiative with demonstrated ability to work independently, manage multiple projects and meet timelines

Pay Range: 

$87,000 - $109,000

Education, experience, location and tenure may be considered along with internal equity when job offers are extended.

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

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 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 stand; walk; 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 may be expected to work with electronic equipment (always being aware of one's environment and taking proper precautions is required). The noise level in the work environment is usually moderate.

Employee may be responsible for moving and/or generating hazardous waste for treatment, storage and disposal. Affected employee will need to be familiar with the applicable training requirements included in the customized 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.

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