17 Quality Control Specialist Jobs in Lexington, KY
Piramal Pharma Limited is Hiring a Quality Control Specialist Near Lexington, KY
Job DescriptionKEY RESPONSIBILITIES
- Design, develop, maintain, and initiate continuous improvement activities for the material specifications preparation/revisions and execution until it is processed for approval.
- Author and reviewer for test method review, risk assessments, change controls, SOPS, specifications, etc.
- Complete activities in compliance to applicable SOPs, specifications, and compendia requirements in an efficient and high quality manner.
- Evaluate compendia monographs, plan for and order reagents, supplies, instrumentation requirements
- Work closely with others in a team environment within the Quality Control Laboratory and act as an integral team member on multidisciplinary teams that provide support for Manufacturing and Product Development.
- Coordinates and participates in material review meetings and/or batch readiness meetings.
- Maintain schedule routine maintenance of laboratory instruments for follow up repairs and/or tracking the calibration activities for timely completion
- Working closely with validations team to complete the required tasks for Instrument qualifications process
- Required assistance on record keeping for Laboratory personnel training matrix updates periodically
- Purchasing of laboratory reagents and consumables.
- Perform testing, analysis and data reporting for test samples as needed.
- Inform budgetary decisions for material testing costs.
- Ensure maintenance and calibration of analytical instruments in compliance with SOPS and GMP regulations.
- Develop the Materials testing Training program for QC analysts and lead the training activities.
- Maintain regulatory compliance in instrumentation records, test result documentation, usage logbooks, maintenance logbooks and all other project or material specific documentation with particular attention to accurate record keeping.
- Perform all work according to applicable safety procedures using good laboratory techniques and using safe operation of laboratory equipment.
- Perform additional duties as assigned by laboratory management
WORK Experience
- 5 years of experience in a pharmaceutical laboratory or regulated environment
- Hands-on experience performing quality control work within a laboratory and operating analytical testing equipment
- Experience working with potent, cytotoxic materials and parenteral drug products preferred
- Knowledgeable in general analytical techniques
- Knowledgeable in analytical testing equipment and related procedures.
- Knowledge of USP, FDA, and ICH requirements and procedures, EU/EP and PMDA experience a plus
- High proficiency operating analytical testing equipment and troubleshooting
- Ability to handle multiple assignments and projects with competing priorities while independently managing time is critical.
- Highly motivated, self-directed, detail oriented, quality minded with strong organizational skills.
- Operates with a sense of urgency in a fast-paced environment
- Ability to comprehend and follow standard operating procedures and test methods.
- Proficient in Microsoft Office Applications (Word, Excel, PowerPoint etc.), with ability to learn and master new computer applications.
- Strong technical writing skills
- Able to exercise independent intellectual judgment using data driven decision making
- Excellent oral and written communication skills
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunityPiramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.
We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.
About The TeamPiramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.
Job Info
- Job Identification 4837
- Job Category Production
- Posting Date 06/21/2024, 06:22 PM
- Degree Level High School Diploma/GED/GCSE/SSE/HSE
- Job Schedule Full time
- Locations 1500 BULL LEA ROAD,, Lexington, KY, 40511, US
Job Summary
Full Time
Medical Technology
$89k-117k (estimate)
06/23/2024
07/21/2024
NETAJINAGAR, MAHARASHTRA
200 - 500
2020
NANDINI AJAY PIRAMAL
$10M - $50M
Medical Technology
Related Companies
The job skills required for Quality Control Specialist include Quality Control, SOP, Microsoft Office, Written Communication, Chemistry, Calibration, etc. Having related job skills and expertise will give you an advantage when applying to be a Quality Control Specialist. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Quality Control Specialist. Select any job title you are interested in and start to search job requirements.
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If you are interested in becoming a Quality Control Specialist, you need to understand the job requirements and the detailed related responsibilities. Of course, a good educational background and an applicable major will also help in job hunting. Below are some tips on how to become a Quality Control Specialist for your reference.
Step 1: Understand the job description and responsibilities of an Accountant.
Quotes from people on Quality Control Specialist job description and responsibilities
Quality Assurance (QA) Specialist duties and responsibilities Providing management and control of the quality assurance processes Maintaining the quality of products.
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Quality control specialists work as part of a manufacturing team, maintaining records of defective materials and ensuring that defective parts are repaired, re-tested, or pulled from production.
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The quality control specialist may provide these reports to supervisors or plant managers to help them make decisions about manufacturing processes and practices.
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Quality control specialists need to possess a high level of attention to detail and familiarity with product specifications and expectations.
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Measure the quality of products using a pre-defined set of criteria.
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Step 2: Knowing the best tips for becoming an Accountant can help you explore the needs of the position and prepare for the job-related knowledge well ahead of time.
Career tips from people on Quality Control Specialist jobs
These roles require highly organized specialists with meticulous attention to detail.
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Knowledge of Quality Assurance and training principles.
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There are certain skills needed to become an effective quality control specialist.
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Get Experience Required for Certified Quality Engineer Certification.
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