Senior Analyst, QA Stability (Pharmaceuticals)CONTRACT PHARMACAL CORP • Hauppauge, NY, US
Senior Analyst, QA Stability (Pharmaceuticals)
CONTRACT PHARMACAL CORP • Hauppauge, NY, US
[job_card.30_days_ago]
[job_preview.job_type]
- [job_card.full_time]
[job_card.job_description]Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, or a related scientific field. Master’s degree a plus. Proven experience (typically 5+ years) in stability studies within the pharmaceutical, OTC, and dietary supplement industries. Strong understanding of cGMP, GLP, and ICH guidelines related to stability testing. Proficiency in analytical techniques used in stability testing, including, but not limited to, HPLC, GC, and dissolution testing. Expertise in data analysis, interpretation of stability data, and experience with statistical software packages (e.g. Minitab). Excellent written and verbal communication skills, including the ability to write clear and concise protocols, reports, and regulatory documents. Demonstrated analytical and problem-solving skills, with keen attention to detail. Ability to work both independently and collaboratively within a team environment. Adaptability and flexibility to meet changing project needs and timelines in a dynamic environment. Skilled in using Microsoft Office suite. Familiarity with Microsoft Access database is a plus. Ability to interact, and fluently work in electronic ERP, QMS, LIMS for managing stability data, and similar computer systems. Required to use hands / fingers to handle documentation, file, and operate computer controls. While performing the duties of this job, the employee is regularly required to stoop, kneel, crouch, stand, bend, sit, talk, hear, climb stairs or walk for long periods. The employee may lift and / or move up to 50 lbs. Specific vision abilities required include close vision, color vision, and ability to focus. Required to be present in-house to provide immediate department management, and collaborate with customers, department directors, direct reports, peers, and supervisors daily. Work environment in laboratory and production operations facilities include close proximity to heavy machinery, loud noises, and pharmaceutical powders. Potential to move between production operations sites / areas to complete job functions; regular, ongoing travel throughout geographic areas on a continual basis as normal scope of role requiring use of personal vehicle. Employee work hours / schedule and / or shift are subject to change based on business needs and Management discretion. May supervise QA Stability employees. As needed.
Job Description
Job Description
Description : Position Summary :
The QA Stability Sr. Analyst is primarily responsible for being the technical subject matter expert for the stability and retention program which includes drugs, dietary supplements and food products. The Sr. Analyst will develop stability protocols, produce product stability and shelf-life reports in support of product expiry, perform stability assessments, and support the stability and retention sample inventory management aspect of the program.
Responsibilities : Responsibilities include, but are not limited to :
- Design, execute, and document stability studies to assess product shelf-life and storage conditions. Approve related protocols as applicable.
- Write and / or review related Standard Operating Procedures. Approve such SOPs as applicable.
- Write and / or review Deviation Reports related to the stability program.
- Analyze and interpret stability data and documenting results in compliance with regulatory standards.
- Assess the stability impact of changes outlined in Management of Change.
- Calculate product shelf life, prepare shelf-life reports.
- Troubleshoot analytical and product problems, including investigating out-of-specification or unexpected results
- Provide stability reports to customers and for APR reports.
- Support the management of retain and stability samples in storage areas / chambers.
- Support the monitoring of stability chambers and the stability room and ensure units are operational and within specification.
- Maintain and support any related electronic documentation and sample management systems.
- Collaborate with cross-functional teams, such as quality assurance, manufacturing, regulatory affairs, business development, and account services to ensure product stability and quality, and align with customer expectations.
- Support audits, inspections and requests from health authorities, third parties such as UL, and customers.
- Lead continuous improvement initiatives in all aspects of the stability program.
- Other responsibilities as assigned by management.
Requirements :
Education and Experience :
Skills. Knowledge and Abilities :
Physical Demands :
Work Environment :
Supervisory Responsibilities :
Personal Protective Equipment or Attire Required for Position :
Pay Range :
$70,000 - $90,000 per year
[job_alerts.create_a_job]
Qa Analyst • Hauppauge, NY, US
[internal_linking.similar_jobs]
Hours : Part-time up to 17 hours per week .Closing Date : Open until filled, with priority consideration given to applicants who submit materials.
For more information about CT State Communi...[show_more]
Our fundamental belief at Freudigman & Billings is that children learn best in the context of supportive relationships.We are committed to helping students better understand how they learn and ...[show_more]
Presidio, Where Teamwork and Innovation Shape the Future.AtPresidio, we're at the forefront of a global technology revolution, transforming industries throughcutting-edge digital solutions and next...[show_more]
We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more] We are looking for a finance professional to join our team to train AI models.You will measure the progress of these AI chatbots, evaluate their logic, and solve problems to improve the quality of ...[show_more] 
Host Healthcare is seeking a travel CT Technologist for a travel job in Fairfield, Connecticut.Job Description & Requirements.
Pay package is based on 8 hour shifts and 40 hours per week (subjec...[show_more]
Princeton Staffing Solutions is seeking a travel Board Certified Behavioral Analyst (BCBA) for a travel job in Norwalk, Connecticut.
Job Description & Requirements.Board Certified Behavioral Ana...[show_more]
AlliedTravelCareers is working with Triage Staffing LLC to find a qualified Pathology Assistant in Huntington, New York, 11743!.
Travel Laboratory : Pathologists' Assistant Huntington.Shift Details : ...[show_more]
Centra Healthcare QIA is seeking a School Services Board Certified Behavioral Analyst (BCBA) for a job in Norwalk, Connecticut.
Job Description & Requirements.Board Certified Behavioral Analyst ...[show_more]
Aon is looking for a Director - Compensation, Data Solutions.Aon is looking to welcome a data-driven consultant to support our Data Solutions team, focusing on clients in the.This role is ideal for...[show_more]
Schedule : Primarily MondayFriday, 9 : 30 a.At Freudigman & Billings, we believe that students learn best in the context of supportive relationships.
Our Test Prep program helps students prepare fo...[show_more]
Earn up to $16 USD / hourly and work fully remotely and flexibly.Outlier, a platform owned and operated by Scale AI, is looking for.
If you're passionate about improving models and excited by the futu...[show_more]
Are you looking to Optimize your life? Start your exciting path to a rewarding career today!.We are Optimum, a leader in the fast-paced world of connectivity, and we're on the hunt for enthusiastic...[show_more]
What makes this role important at Ipsos : .As a Research Analyst, you play a role in supporting the delivery of strategic insights to our clients through the execution of research projects.Your work ...[show_more] AlliedTravelCareers is working with Host Healthcare to find a qualified MRI Tech in Fairfield, Connecticut, 06824!.Host Healthcare is an award-winning travel healthcare company with an immediate op...[show_more] 
Since 1969, Sensitron Semiconductor has been a manufacturer of discrete semiconductors and microelectronics for aerospace, defense, medical, and other high reliability markets, and applications.Our...[show_more]
Epic Orders / LAB / Blood Bank / POCT (Point of care test).Supports and enhances products on larger, more complex or multiple products for enterprise resource planning, budgeting, data warehousing, and f...[show_more] Aon is looking for a Director, Data Solutions - United States.Aon is in the business of better decisions.At Aon, we shape decisions for the better to protect and enrich the lives of people around t...[show_more]
Adaptive Technology Specialist
Connecticut State Community College • Norwalk, CT, US
[job_card.part_time]
[last_updated.last_updated_30] • [promoted]
AP Environmental Science Instructor- Part-Time
Freudigman & Billings LLC • Westport, CT, US
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Solutions Consultant
Presidio Networked Solutions, LLC • Hauppauge, NY, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Remote Investment Analyst – AI Trainer ($50-$60 / hour)
Data Annotation • Norwalk, Connecticut
[filters.remote]
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Remote FinTech Product Analyst - AI Trainer ($50-$60 / hour)
Data Annotation • Norwalk, Connecticut
[filters.remote]
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Travel CT Technologist
Host Healthcare • Fairfield, CT, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Travel Board Certified Behavioral Analyst (BCBA)
Princeton Staffing Solutions • Norwalk, CT, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Travel Pathology Assistant - $2,886 per week in Huntington, NY
AlliedTravelCareers • Huntington, NY, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
School Services - Board Certified Behavioral Analyst (BCBA)
Centra Healthcare QIA • Norwalk, CT, US
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Data Solutions Director
Aon • Norwalk, CT, United States
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]
Test Prep Operations Associate
Freudigman & Billings LLC • Westport, CT, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Remote Text Quality Evaluator
Outlier • Westport, CT, United States
[filters.remote]
[job_card.full_time]
[last_updated.last_updated_variable_days] • [promoted]
Product Analyst II
Altice USA • Bethpage, NY, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Research Analyst, Creative Excellence
Ipsos-Insight, LLC • Norwalk, CT, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Travel MRI Tech - $2,843 to $3,022 per week in Fairfield, CT
AlliedTravelCareers • Fairfield, CT, US
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
Documentation Control Specialist
Sensitron Semiconductor • Hauppauge, NY, United States
[job_card.permanent]
[last_updated.last_updated_variable_days] • [promoted]
Senior Epic Analyst (Orders / Lab / Blood bank / POCT) - Senior Product Services & Management Analyst
Northwell Health • Melville, NY, United States
[job_card.full_time]
[last_updated.last_updated_30] • [promoted]
HCS Rewards Solutions Director II
Aon • Norwalk, CT, United States
[job_card.full_time] +1
[last_updated.last_updated_30] • [promoted]