Supervisor, Manufacturing Quality Assurance in Albuquerque, NM  

1 day shift, 1 night shift

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! 

Summary:

Manufacturing Quality Assurance is responsible for coordinating all necessary activities to support daily product manufacturing and product lot release. Additionally, MQA is the primary Quality contact for all internal customers with respect to product, process, and material issues involving site operations. 

Coordinates overall operations of the Manufacturing Quality Assurance function.  This includes:

Daily support of manufacturing operations including in-process inspection, final product inspection, on the floor batch record review, validation support, and routine operations quality support, and interface with customers’ batch release questions.

Ensure products manufactured meet regulatory, corporate and customer requirements for quality, safety and efficacy.

Essential Duties and Responsibilities:

Supervise the Manufacturing Quality Assurance activities, to include on the floor batch record review and Quality Assurance oversight of manufacturing processes.  On call to answer quality questions from Quality Assurance and Production employees as needed.  Provide manufacturing and Quality Assurance technical expertise to internal departments. Provide training on cGMPs to the QA group and Production as needed.  Provide support on validation report closure, change control, investigation approval and other QA systems related issues.  Support strategic/global projects by working with all plant management groups on new products, changes to products, and services to achieve a consistent approach to Quality as needed.  Support quality and compliance process improvements and goals for the sites using current regulations and best-demonstrated practices as needed.  Assist in effective and efficient continuous quality and cost improvement efforts as needed. Hire, train and develop MQA staff and conduct Performance Reviews to assure highly effective, team-oriented contributors. Develops and support departmental strategic goals to assure the highest quality standards and regulatory compliance.  Serves as resident QA expert in support of all manufacturing quality assurance functions (product release, product inspection, batch record reviews, compliance) and resolution of issues on the production floor Other duties may be assigned.

Supervisory Responsibilities:

Directly supervises at least 5 employees in Quality Systems. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

Qualifications: 

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.

Education and/or Experience:   

BS or BA in Science, Chemistry or Biology. Minimum of 3-5 years of progressively greater responsibilities in the pharmaceutical products/medical services industry, including QA, Regulatory, Operations, Project, Technical, and Laboratory experience.  Including 3 years in Quality Assurance or Regulatory Compliance Management. Including 3 years in an aseptic/sterile product facility required. Demonstrated understanding of laboratory, manufacturing, packaging, regulatory, compliance, and quality assurance requirements for biological and drug product manufacturing.  Experience strongly preferred working with third-party contract manufacturing in the Pharmaceutical industry

Language Skills:  

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 effectively present information and respond to questions from managers and customers.

Mathematical Skills:     

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.  Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.

Reasoning Ability: 

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.

Computer Skills:   

To perform this job successfully, an individual should have knowledge of Manufacturing software; Spreadsheet software and Word Processing software.

Other Skills and Abilities:                                             

Excellent Communication skills, both verbal and written Ability to organize time in order to successfully manage multiple projects and priorities Ability to read, understand, interpret and implement technical writing and instructions. Effective inter-personal relation skills, while maintaining the adaptability to achieve company goals Verbally expresses ideas and facts in a clear, logical, concise and in accepted grammatical style. Willing to be on call to answer questions from production 24hours/7 days a week.  Root cause analysis trouble-shooting experience.  Knowledge of aseptic processing technique.  Ability to train and advise QA professionals and production personnel.  Knowledge of quality, regulatory and legal standards including USP, EP, JP, GLP, GMP, EPA, OSHA, ICH, DEA, MOH, EMEA, 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 and Sample Distribution per PDMA Prescription Drug Marketing Act.  Provides leadership in supporting audits and services as the resident QA expert at site and among departmental staff.  Must have demonstrated ability to work independently and as a team leader.  Must show innovative development techniques and strategic thinking abilities. 

Other Qualifications:

Must pass background check Must pass drug screen                    

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.

Note

This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employees will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorized to give instructions or assignments. All duties and responsibilities are essential functions and requirements and are subject to possible modification to reasonably accommodate individuals with disabilities. To perform this job successfully, the incumbents will possess the skills, aptitudes, and abilities to perform each duty proficiently. Some requirements may exclude individuals who pose a direct threat or significant risk to the health or safety of themselves or others. The requirements listed in this document are the minimum levels of knowledge, skills, or abilities. This document does not create an employment contract, implied or otherwise, other than an “at will” relationship.

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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