- Review all Stability documentation provided by customer prior to the initiation of a new study.
- Maintain documentation for stability samples including testing records, protocols, excursion logs and trend reports.
- Responsible for placing new samples on stability, pulling samples to be submitted to the lab for testing, working with the Stability Lead Chemist to ensure timely testing of samples, and generating CoA's/trend reports for completed testing.
- Monitor alarms and notify management of excursions.
- Initiate and complete deviations, CAPA's, Investigations, OOS' and change controls related to the stability program under the direction of management.
- Perform data review on all types of analytical testing performed in the lab, including but not limited to, Identification testing, Wet Bench testing, Titration, HPLC, GC, ICP-MS, etc.
- Generate Certificates of Analysis for completed Routine QC testing and Stability testing.
- Generate Trend Reports for Stability studies.
- Assist with internal facility and system audits on a regular basis.
- Participate in external audits involving customers and regulatory agencies.
- Support the lab and other quality operations as needed.
- Bachelor of Science in Chemistry or a Science related field.
- Minimum of three (3) years of experience in a pharmaceutical environment/cGMP laboratory.
- Two (2) - five (5) years in Quality Control.
- Experience with reviewing all forms of Analytical Chemistry Data.
- Working knowledge of cGMP/GLP, USP/NF, ICH and FDA regulations.
- Knowledge of working with a Laboratory management system (LIMS).
- Knowledge of Microsoft Office suite (Word, Outlook, Teams and Excel) required.
- Excellent communication skills; fluent English (oral & written) required.
- Able to work independently and with minimal supervision.
- Strong organizational skills, ability to prioritize multiple projects, detail oriented.
- Balance Your Life - PTO, vacation policy and paid statutory holidays
- Invest in your health - Group Benefit plan and health savings account
- Your Future is Bright - Opportunities to learn and grow within CED
- Save for your Future - 401k plan retirement
- Help us grow - Employee Referral Program
- We like to have fun - company events throughout the year
-
ECMO Specialist RN
5 days ago
Baylor Scott & White Health Irving, United States Full timeJoin Baylor University Medical Center as a Registered Nurse and be part of something better · ECMO ICU Opportunities · The ECMO ICU is looking for experienced ECMO Specialist RNs who strive to deliver the highest quality care for our ECMO population. Come join our ELSO Platinum ...
-
Legal Intake Specialist
1 week ago
Intake National Irving, United StatesWe partner with high profile attorneys to evaluate and qualify potential client cases and provide rapid response intake services. You will be working hand-in-hand with our internal investigation team, outside firm case and intake managers, and attorneys for the firms. · We are a ...
-
Skyline Solutions Irving, United StatesCompany · The business unit thyssenkrupp Dynamic Components is one of the leading automotive suppliers and development partners for highly complex drive technologies. With around 3,500 employees, we produce 27 million drive components per year at a total of ten locations in Germa ...
-
Gen AI Developer/Specialist
1 week ago
Simple Solutions Irving, United StatesRole: Gen AI Developer/Specialist · Location: Irving, TX · Client: Banking Client · Description for Internal Candidates: · We are seeking a talented and experienced Gen AI developer/specialist with Python development experience a MUST HAVE to join our growing team. You will play ...
-
Gen AI Developer/Specialist
2 weeks ago
Simple Solutions Irving, United StatesRole: Gen AI Developer/Specialist · Location: Irving, TX · Client: Banking Client · Description for Internal Candidates: · We are seeking a talented and experienced Gen AI developer/specialist to join our growing team. You will play a key role in designing, developing, and implem ...
-
Parts Specialist
2 weeks ago
Zero Zone, Inc. North Prairie, United States**Who** **Are** **We?** · Have you ever gone into a grocery store or convenience store for things like milk, bagged salads, or frozen pizza? The coolers and freezers you find those and other food products in are what we do Zero Zone is a manufacturer of reach-in and open refriger ...
-
Automotive Inventory Specialist
2 weeks ago
EchoPark Automotive Grand Prairie, United States**Company Description** · EchoPark Automotive is one of the fastest growing brands within the automotive industry. We are building a business based on doing things the right way. From the way we treat our guests, take pride in our work and share opportunities for our employees to ...
-
Payroll Specialist
4 days ago
First Assured Quality Systems LLC Grand Prairie, United States**Job Overview**: · **Hours**: Monday-Friday 8 am to 5 pm · This position is in office only. · Pay: $23-26 per hour depending on experience · **Responsibilities**: · - Gather information on hours worked for each employee · - Calculate the correct amount incorporating overtime, de ...
-
Pricing Specialist
4 days ago
Republic National Distributing Company Grand Prairie, United StatesRepublic National Distributing Company (RNDC) is a family-owned business with roots extending before Prohibition that has evolved into one of the nation's largest wine and spirits wholesalers. Our success is grounded in our core values of Family, Service, Accountability, Honesty, ...
-
Operations Specialist
2 weeks ago
Lime Dallas, United StatesWe are looking for Operations Specialists to join our team. In this role, you'll help support our daily operations including deploying and retrieving our fleet of shared electric vehicles. This is an exciting role where you will wear many 'helmets' to support the Lime team. · **W ...
-
Integrated training as a commercial specialist"
3 weeks ago
BlueWave Solutions La Prairie, United StatesWhat will you do with your talents at La Prairie?You plan and organize sales. · You procure goods and ensure their availability. · You present goods and provide services. · You determine and analyze business indicators. · You advise customers, lead employees, and manage business ...
-
Employment Specialist
1 week ago
Volunteers of America Texas Dallas, United States**VOA - Texas** · Are you looking for a job that makes a difference? Do you have a passion for helping others? We may be the right organization for you: VOLUNTEERS OF AMERICA TEXAS. · **Location**: Dallas, TX · **Pay**:$50,000 per year · **Job Type**:Full-Time · **Why you'll love ...
-
Quantum Ventures La Prairie, United StatesYOUR TRAINING ELEMENTS · As a good host, you love to spoil your circle of friends and family. You enjoy taking care of the decoration of the location for celebrations. Then you can turn your passion into a profession with us. As a specialist for restaurants and event catering, t ...
-
Nexus Dynamics La Prairie, United StatesDo you love being able to help people in your nursing profession and value the joy of work? · ▸ If a respectful work environment is important to you · ▸ If you are looking for a strong team and a good working atmosphere · ▸ If appreciation and recognition motivate you · ▸ If a ba ...
-
rn ecmo icu
59 minutes ago
Baylor Scott & White Health Irving, United States Full timeJoin Baylor University Medical Center as a Registered Nurse and be part of something better · ECMO ICU Opportunities · FT Night 7:00pm -7:00am · The ECMO ICU is looking for experienced ECMO RN's who strive to deliver the highest quality care for our ECMO population. Come join o ...
-
rn ecmo icu
59 minutes ago
Baylor Scott & White Health Irving, United States Full timeJoin Baylor University Medical Center as a Registered Nurse and be part of something better · ECMO ICU Opportunities · FT Night 7:00pm -7:00am · The ECMO ICU is looking for experienced ECMO RN's who strive to deliver the highest quality care for our ECMO population. Come join o ...
-
rn ecmo icu
5 days ago
Baylor Scott & White Health Irving, United States Full timeJoin Baylor University Medical Center as a Registered Nurse and be part of something better · ECMO ICU Opportunities · The ECMO ICU is looking for experienced ECMO/CVICU RN's who strive to deliver the highest quality care for our ECMO population. Come join our ELSO Platinum Cent ...
-
rn ecmo icu
59 minutes ago
Baylor Scott & White Health Irving, United States Full timeJoin Baylor University Medical Center as a Registered Nurse and be part of something better · ECMO ICU Opportunities · FT Night 7:00pm -7:00am · The ECMO ICU is looking for experienced ECMO RN's who strive to deliver the highest quality care for our ECMO population. Come join o ...
-
SAP Lead Architect, FP&A Solutions
5 days ago
MCKESSON Irving, United States Full timeMcKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you a ...
-
Housing Placement Specialist
2 weeks ago
Maharaja Enterprises LLC Dallas, United States**IT'S TIME FOR A CHANGE, START 2024 OFF THE RIGHT WAY** · **Maharaja Enterprises LLC - Creative Financing Experts** · **$1000 per closing and 10% of rental income** · **Position: National Housing Placement Specialist** · **Location**: Remote · **Job Type**: Full-Time · **Company ...
QC Specialist II - Irving, United States - Medisca
Description
A Medisca Partner, CED Analytical Labs is an analytics testing laboratory that delivers customized solutions with an unwavering commitment to quality and innovation that their customers can always count on. Offering worry-free and agile testing services at the highest standards of quality, CED Analytics supports partners in the pharmaceutical compounding, life-science, and healthcare industries. Committed to Partners in Wellness, CED Analytics offers an unfailing devotion to improving lives across a multitude of needs and multitude of people.The QC Specialist II will be responsible for the coordination and overall management of the CED Stability program. This position is responsible for all aspects of the stability process, including placing new samples on stability, recording information in the LIMS database, pulling samples, working with the lab to schedule testing, reviewing laboratory data and generating Certificates of Analysis to send to the customer in a timely manner. The ability to conduct investigations, deviations, change controls and CAPA's is required. The successful candidate will also participate in both internal and external audits, review routine QC testing data, and support other QC operations as needed.
Your key responsibilities
Stability
Skills, knowledge and abilities
We thank all applicants for their interest; however, only candidates to be interviewed will be contacted.
We are an equal opportunity employer.
#LI-Onsite