Manufacturing Quality Assurance Analyst

Manufacturing Quality Assurance Analyst I, Albuquerque, NM

Night Shift

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.

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 with matching contributions

• Learning platform

• And more!

Summary:

The Manufacturing Quality Assurance (MQA) Analyst I role is an entry-level, developmental position. The MQA Analyst I will collaborate with the manufacturing team to provide support in process oversight and first-level decision-making activities. A successful candidate will exhibit a strong safety-focused quality mindset, a capacity for critical thinking, and an aptitude for understanding written SOPs. The MQA Analyst I must communicate effectively during collaborations with production partners and escalate issues urgently to facilitate timely decisions on the path forward.

The MQA Analyst I will routinely work collaboratively with management, frontline manufacturing and support group technicians, as well as with senior members of the MQA OTF team.

Responsibilities

• Perform daily audits

• Perform room inspections

• Review documentation

• Communicate effectively

• Collaborate intra and interdepartmentally

• Read/interpret SOPs to ensure compliance

• Maintain up to date trainings

• Other duties as assigned

Qualifications

• High school diploma or general education degree (GED)

• FDA manufacturing regulated industry experience in an aseptic manufacturing environment, preferred

• Operations or quality assurance in any industry, preferred

Other

Qualifications:

• Must pass a background check

• Must pass a drug screen

• May be required to pass Occupational Health Screening

• Must pass pre-employment assessment

• Must be able to obtain and maintain gowning certification

• Must be able to obtain and maintain media qualification

• Must be able to wear a respirator

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

Physical Demands:

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.

The essential physical demands will vary for each Curia position.

All positions may require regular or occasional lifting, pushing and pulling up to 10 pounds, frequently; up to 25 pounds occasionally; and up to 50 pounds infrequently. Additionally, all positions entail regular sitting, standing and reaching, with some roles requiring prolonged periods of time for each activity. Visual acuity, both close and distant, along with depth perception is necessary in each role, with or without corrective lenses.

Please note that employees are prohibited from wearing contact lenses in work areas with exposure to cleaning agents. Hand and finger dexterity are integral to all positions, with specific activities varying from typing to manipulating maintenance tools or operating keypads, switches, and buttons. Occasional stooping, kneeling, twisting, crouching, crawling and balancing are also part of each position’s physical requirements. Certain roles may involve climbing and working at elevated heights as well.

Work Environment:

The work environment characteristics, described below, 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.

The working environments will vary for each Curia position. The employee may be required to work in an office, manufacturing, or warehouse environment. The office environment is designed for comfort and productivity, with room temperature settings maintained for optimal working conditions. It is common to hear conversational noise in the background. The pharmaceutical manufacturing environment is sterile. Therefore, aseptic gowning is required.

Personal protective equipment (nitrile gloves, clean room socks, face-shields, safety glasses, aprons, steel-toed shoes and powered air purifying respirators) is necessary, depending upon the task  employee may be exposed to wet and/or humid conditions, confined areas, and refrigerator or freezer temperatures when working in a sterile environment. The warehouse environment is typically set at a controlled temperature but the employee may be exposed to refrigerator or freezer temperatures when retrieving materials.

Some positions may…