Search jobs > Lexington, KY > Quality assurance specialist

Senior Material Release Quality Assurance Specialist

Piramal Group
Lexington, KY, United States
Full-time

Key Responsibilities

  • Review executed batch records and executed protocols and meet the batch disposition timelines as per business requirement.
  • Assist in review, release of materials, components used in planning and batch manufacturing.
  • Prepare and summarize data associate with site metrics ,write, read, and revise technical reports
  • Must have QA core experience, and have the ability to train and support staff regarding QA responsibilities as needed
  • Conduct GMP investigations; specifically root cause analyses, risk assessments, and impact evaluations
  • Adhere to all applicable regulations, policies, and procedure for health, safety and environmental compliance.
  • Execute the assigned training and development plan.
  • Troubleshoot systemic GMP issues
  • Provide leadership on projects and within systems that interface with other departments
  • Provides SME support, review and approval during meetings, audits, investigations, technical reports, etc.

Key Interactions

INTERNAL STAKEHOLDERS NATURE / PURPOSE OF THE INTERACTION Manufacturing / Operations Inform team of necessary documentation corrections Quality Control Collaboration and problem solving during standard and non-routine events.

Warehouse Relay information related to documentation needed for batch disposition. EXTERNAL STAKEHOLDERS NATURE / PURPOSE OF THE INTERACTION Clients Occasional interaction with clients during visits or tours

Physical Demands

  • Ability to wear gowning materials for extended periods of time
  • Required to maintain good personal hygiene
  • Frequent lifting, bending, stooping, squatting, pushing and pulling can be expected
  • Periodic lifting up to pounds
  • Long periods of standing and walking

Work Envoirnment

  • This job primarily operates in a high demand office and manufacturing setting, periodically works inside the manufacturing core
  • Potential limited exposure to hazardous chemicals
  • Piramal Pharma Solutions is engaged in the business of pharmaceutical research and contract pharmaceutical manufacturing.

As such, all PPS staff work in or nearby either chemical / pharmaceutical research or chemical / pharmaceutical manufacturing equipment and processes.

  • Personal protective equipment including safety glasses, lab coats, gloves, specialized clothing including laboratory uniform and appropriate shoes may be required in areas associated with this position.
  • 30+ days ago
Related jobs
Piramal Group
Lexington, Kentucky

Assist in review, release of materials, components used in planning and batch manufacturing. Manufacturing/Operations Inform team of necessary documentation corrections Quality Control Collaboration and problem solving during standard and non-routine events. Ability to wear gowning materials for ext...

Promoted
InsideHigherEd
Lexington, Kentucky

STEPS Dental QA Compliance Analyst. Under the direction of Senior QA Safety Manager lead and run the facility safety committee. Under the direction of Senior QA Safety Manager team members, maintains updated data and any applicable review/audit findings monitoring, tracking, and reporting, including...

Promoted
Gray
Lexington, Kentucky

Through coordination with the Project Manager/Site Manager, direct activities and coordinate the day- to-day quality control system and procedures for the company, from project start up to completion. Perform administrative set up of projects within the quality program database, assist in the suppor...

Promoted
Quality Talent Group
Georgetown, Kentucky

About the job Registered Nurse Home Infusion Specialist. All TDD Specialist Nurses will be provided the ANCC accredited Nurse Fellowship Program upon hire. Promotes integrative care techniques to assist the patient with symptom management to improve quality of life. ...

Adient
Georgetown, Kentucky

The Quality Engineer assists suppliers in developing quality systems which will improve quality and cost. Bachelor's degree with statistical background or certified quality or reliability engineer through or 3 to 5 years experience in quality control or quality assurance. Write and implement proced...

Choctaw Global
Lexington, Kentucky

The Quality Assurance Manager holds an instrumental role in safeguarding the integrity and compliance of logistical management and facility service maintenance operations, ensuring adherence to stringent government regulations and quality standards. Develop and maintain detailed procedures for quali...

Nationwide Technical & Executive Search
Kentucky, US

The Quality Manager will oversee development of the Quality Plan ensuring customer expectations are met, train every employee in the quality requirements of his/her job and the Tools of Quality, provide staff support to plant supervision in day-to-day quality issues, and monitor the Quality Sys...

Bering Straits Native Corporation
Lexington, Kentucky

Three years’ experience as a quality control manager on industrial or commercial projects / overseeing the safety of construction / site supervision. The candidate will be performing all facets of the Bering Straits East Coast model to include field superintendence, quality control management, submi...

Smartcop, Inc.
Kentucky, United States
Remote

We are seeking a Quality Assurance Analyst to join our team. Knowledgeable of concept practices and procedures commonly used in software quality assurance. Effective testing skills:proficient in test planning and execution and using test methodologies to identify software defects, applying software ...

Professional Outlook
Lexington, Kentucky

They will perform quality engineering reviews/audits of design documentation for compliance with stated requirements, including vendor quality manuals and company quality records. The Quality Engineer will provide support in carrying out Quality Functions to meet customer requirements. Plant Quality...