Quality Investigations Specialist II

Job Type: Location Type: On-site

 

Job Description

Quality Investigation Specialist II in Rensselaer, NY

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 Quality Investigation Specialist II plans and conducts activities concerned with the quality assurance of industrial processes, materials, and products. The role is responsible for overseeing and providing support for GMP investigations, internal audits, and customer complaint investigations. This role serves the Quality Assurance Department by implementing all procedures leading to compliant, valid, and documented release of drug, biologic product, or medical device by performing the following duties personally or through subordinate specialists. The Quality Assurance Specialist II participates in, writes and/or closes investigations. This requires maintaining budgetary targets and delivering earnings and growth to the company.

Supervisory Responsibilities

This position may directly supervise up to four employees in QA, which requires the position to carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Responsibilities

• Provide QA oversight and subject matter expertise for GMP investigations
• Review GMP documents for company and contractor/customers
• Support product complaints, deviations, and failure investigations
• Contribute to Curia’s core values of Quality, Timeliness, Communication and Profitability
• Conduct investigations or closure of major investigations and customer complaints
• Perform root cause analysis and implementation of corrective action for process related concerns
• Recommend and enact changes to applicable SOPs
• Support Curia Compliance department during FDA and other agency inspections as well as customer and internal audits
• Maintain a working knowledge of government and industry quality assurance codes and standards
• Participate in site or global projects and improvement efforts, as needed
• Establish and maintain effective working relationships with Clinical Supply Chain Management, Production and Warehouse/Distribution staff, corporate and site Quality, study management and regulatory affairs
• Education, experience, certification and licensures

Qualifications

• BA/BS Degree in Biology or Chemistry or a a relevant field and 3 years of related work experience OR
  MA/MS Degree in a relevant field and 1 year of related work experience
• Relevant experience in quality assurance and/or regulatory experience in the Pharmaceutical industry with demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing

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

Knowledge, skills and abilities

• Must have knowledge of the US, European and Japanese Compendia requirements for a pharmaceutical facility and an analytical/microbiological laboratory
• Excellent verbal and written communication skills, including the ability to present information to large or small groups, and interact with customers
• Proficient in time and project management. Ability to develop plans and delegate responsibilities
• Ability to work independently and as a team leader
• Able to organize and write clear, concise and complex technical documents, reports, and assessments
• Extensive knowledge of cGMP, EU and other country regulations involved in the technical development and manufacturing processes of pharmaceutical drug products
• Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA and FDA
• Knowledge of Quality Systems as they related to SOP creation and control, Validation of Computerized Systems per Code of Federal Regulations, Chapter 21, Part 11
• Familiar with instrument manufacture-based systems (Chemstation, Empower), laboratory software, and Microsoft Office
• Must also have extensive working knowledge of Documentum, Trackwise, Eduneering, JD Edwards and Batch Record Tracking
• Ability to adapt to frequent changes, delays or unexpected events in a fast-paced work environment and change procedures to best fit the situation
• Ability to research, collect, and analyze complex data and information, synthesize complex problem solutions, and design work flows and procedures based on results
• Excellent customer service skills
• Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions
• Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
• Ability to write reports, business correspondence, and procedure manuals
• Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry
• Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations
• Ability to define problems, collect data, establish facts, and draw valid conclusions
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables

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 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 and stoop, kneel, crouch, or crawl. 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.

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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