Quality Control Analyst I

Quality Control Analyst I (Data Reviewer)

The Quality Control Analyst I (Data Reviewer) is responsible for supporting the Stability & Reference Standard department and commercial projects. The principal responsibility of the Quality Control Analyst I data reviewer is the review and approval of primary analytical data according to cGMP guidelines. The data reviewer will be expected to review analytical data including HPLC, KF, USP testing for compliance and completeness against established SOPs, methods and procedures. The data reviewer will also support QA initiatives when necessary and collaborate with laboratory personnel to review data per cGMP compliance and data integrity. The reviewer should incorporate sound judgement, critical thinking, and cGMP principles to ensure the integrity of the data meet acceptable quality standards. In addition, the reviewer will provide appropriate guidance to analysts, supervisors, and quality personnel to promote compliance for our customers.

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!

Essential Duties and Responsibilities

• Audit laboratory notebooks and raw data.
• Apply technical and regulatory knowledge and judgement to review experimental data for compliance with internal SOPs and quality standards with minimal supervision.
• Trending of stability data to ensure consistency with historical time points and no unexpected results for potential investigations to management as necessary.
• Communicate with analytical scientists, supervisors, and management on technical issues, investigations, and process improvements.
• Review and approve test methods, SOPs, forms, and other documents as necessary.
• Coordinate testing performed at contract testing labs for stability samples etc.
• Verify calculations associated with Stability samples/Reference standards/Raw Materials/Intermediates testing are correctly done.
• Collaborate with lab personnel for data review per cGMP compliance, data integrity.
• Perform other related duties as may be reasonably assigned in the course of business.

Supervisory Responsibilities

This job has no supervisory responsibilities.

Education and Experience - Required

• Bachelor’s with major in Natural Science or Pharmacy or Associates degree with equivalent industrial experience.
• Chemical Hygiene training.
• Other pertinent training/courses.

Preferred

• Experience working in 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 apply mathematical concepts, operations and tasks.
• Proficient use of computer software, including Microsoft Office Suite and instrument manufacture based systems.

Physical Demands

While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to sit; use hands to finger, handle, or feel and reach with hands and arms. The employee is occasionally required to stand; walk; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.

Work Environment

While performing the duties of this Job, the employee is frequently exposed to fumes or airborne particles and toxic or caustic chemicals. The employee is occasionally exposed to wet and/or humid conditions; moving mechanical parts; high, precarious places; risk of electrical shock; explosives; risk of radiation and vibration. The noise level in the work environment is usually moderate.

Pay range: $50,000 - $62,514

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

We do not accept unsolicited assistance from any headhunters or recruitment firms for any of our job openings. All resumes or profiles submitted by search firms to any employee at Curia, in any form without a valid, signed search agreement by an authorized signatory in place for the specific position, approved by Talent Acquisition, will be deemed the sole property of Curia. No fee will be paid in the event the candidate is hired by Curia because of the unsolicited referral.

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.

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