Quality Assurance Specialist II

Quality Assurance Specialist II

Build your future at Curia, where our work has the power to save lives

Curia 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. At Curia, we are on a mission to advance our customers' therapies from curiosity to cure and ultimately to improve patients' lives.

Position overview

The Quality Assurance (QA) Specialist II is responsible for maintaining Quality databases and providing an on-the-floor QA presence and oversight to operations. This role includes identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action. The QA Specialist II primarily works in the cGMP areas to manage adherence to the quality system and assist in and/or initiate the resolution of deviations.

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. Represent Curia Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and correctly documented
2. Review quality control testing for compliance with internal SOPs and specifications
3. Report back to appropriate management as to personnel performance, highlighting those areas and individuals in need of improvement as well as those exceeding expectations
4. Author, review, and/or approve Quality Management System documents, including, but not limited to, change controls, SOPs, deviations, CAPAs, etc.
5. Perform and/or participate in internal audits, external audits, investigations, and/or inspections
6. With supervision, may respond or manage responses to clients regarding manufacturing, testing and/or documentation issues
7. May develop and/or maintain Quality System metrics for management review
8. Provide on the floor support to operations, including coordinating and performing day to day activities as needed
9. May assist in developing and conducting training of personnel to execute production in full accordance with cGMP's and Curia's quality system to ensure real-time compliance
10. May perform QA visual inspection activities when required
11. Participate in regulatory and client audits
12. Other duties as assigned.

Education, experience, certification and licensures Required

1. BA/BS Degree in Chemistry or a relevant field and 3 years of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry
2. OR
3. MA/MS Degree in Chemistry or a relevant field and 1 year of related work experience in pharmaceutical, biotechnology, medical device, and/or cGMP FDA-regulated industry

Knowledge, skills and abilities

• Excellent written and verbal presentation and communication skills
• Strong facilitation skills
• Strong problem-solving skills, with the ability to resolve conflict
• Ability to effectively present information to management and/or peers
• Comfortable working independently and proactively in combination with individuals in other departments across the organization
• Focused self-starter with attention to detail and ability to multi-task
• Strong familiarity with the regulatory requirements of ICH Q7, Q9, Q10, and/or 21CFR210 and 211
• Working knowledge of Microsoft Office or other software as needed

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.

Other Qualifications

• Must pass a background check
• Must pass a drug screen
• May be required to pass Occupational Health Screening

Pay Range: $67,000-$83,000

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