JT829 - SPECIALIST MANUFACTURING

Juncos, Puerto Rico
Contracted
Biopharmaceutical
Experienced
QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing to a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:
  • Support the execution of manufacturing and quality systems, including non-conformances, process validation, procedures, training, and New Product Introductions (NPI).
  • Apply process, operational, scientific, compliance, analytical, and troubleshooting skills to support manufacturing operations.
  • Serve as a primary process owner for assigned production process support systems and assist with process ownership activities for more complex systems.
  • Initiate, revise, and approve manufacturing procedures to ensure documentation accurately reflects current operations.
  • Serve as a document owner and ensure procedures remain current and compliant with applicable requirements.
  • Assess process performance through floor observations, operational data review, and process monitoring.
  • Identify process improvement opportunities and support the planning and implementation of solutions.
  • Provide technical process troubleshooting support to manufacturing operations.
  • Assist in developing training materials and provide training on scientific and technical aspects of manufacturing processes.
  • Support the establishment of process monitoring parameters and control limits.
  • Collect and analyze process monitoring data and support the assessment and resolution of deviations.
  • Support the timely preparation and execution of quarterly process monitoring reports.
  • Ensure manufacturing Non-Conformances (NCs) are appropriately triaged within established timelines.
  • Author and document Non-Conformance investigation reports.
  • Execute corrective actions and support the timely closure of NC/CAPA activities.
  • Monitor incident trends and communicate findings to relevant stakeholders.
  • Review equipment and system Root Cause Analysis (RCA) investigations and support trend evaluations.
  • Assist with the development of process validation protocols and reports.
  • Support execution of process validation activities and collection and analysis of validation data.
  • Participate in regulatory inspections, New Product Introductions, and process or equipment modification activities, as required.
  • Support NPI activities by assessing requirements for documentation, materials, training, and equipment modifications.
  • Assess, prioritize, justify, and provide implementation and project management support for process and equipment modification projects.
  • Assist manufacturing change owners with Change Control Review Board (CCRB) packages impacting manufacturing processes.
  • Participate in the assessment and implementation of special projects and process improvement initiatives.
  • Collaborate with Manufacturing, Process Development, Quality, and other cross-functional teams to resolve technical and operational issues.
  • Support other manufacturing, quality, and engineering activities as assigned.
Qualifications:
  • Bachelor’s degree + 4 years of Manufacturing Operations experience
  • Direct pharmaceutical or biotechnology manufacturing experience.
  • Strong hands-on experience providing floor support in GMP manufacturing operations.
  • Experience authoring, revising, and approving manufacturing procedures.
  • Experience with NC/CAPA investigations and closure.
  • Experience with process validation protocols, execution, and data analysis.
  • Experience supporting NPI activities and Change Control/CCRB packages.
  • Experience with process monitoring, trending, and basic statistical/control charting techniques.
  • Experience leading or participating in cross-functional manufacturing improvement projects
  • Detailed technical understanding of bioprocessing unit operations.
  • Hands-on experience supporting GMP manufacturing operations.
  • Experience providing on-the-floor manufacturing support and assessing process performance through observation and data review.
  • Experience with process troubleshooting and process improvement activities.
  • Knowledge of manufacturing and quality systems, including Non-Conformances, CAPA, Change Control, and process validation.
  • Experience initiating, revising, or maintaining manufacturing procedures and technical documentation.
  • Knowledge of process monitoring, control limits, and basic control charting.
  • Understanding of regulatory requirements and experience supporting regulatory inspections is preferred.
  • Schedule: 8-hour shift, 8:00 AM–5:00 PM.
  • Ability to work overtime based on business needs.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

Share

Apply for this position

Required*
We've received your resume. Click here to update it.
Attach resume or Paste resume
Attach resume as .pdf, .doc, .docx, .odt, .txt, or .rtf (limit 5MB) or Paste resume

Paste your resume here or Attach resume file

Invitation for Job Applicants to Self-Identify as a U.S. Veteran
  • A “disabled veteran” is one of the following:
    • a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or
    • a person who was discharged or released from active duty because of a service-connected disability.
  • A “recently separated veteran” means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.
  • An “active duty wartime or campaign badge veteran” means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.
  • An “Armed forces service medal veteran” means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.
Veteran status


Voluntary Self-Identification of Disability
Voluntary Self-Identification of Disability Form CC-305
OMB Control Number 1250-0005
Expires 07/31/2029
Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Please check one of the boxes below:

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.

You must enter your name and date
Human Check*