Quality Assurance Specialist
Found in: Talent US C2 - 1 week ago
New Brunswick, NJ 100% Onsite
Pay Rate Range: $44 - $45.24/hr W2
Required Skills:
- B.S. in Natural Sciences, Chemistry, Microbiology, Biology, Engineering, Pharmacy or equivalent
- A minimum of five (5) years experience in pharmaceutical, biologics, biotech or related industry with relevant experience with batch record review, deviation and change control oversight experience
- Experience in a Quality Assurance, Quality Control or equivalent function is required
- Experience in the manufacture of drug substance and/or drug product or quality control laboratories is desired
- Knowledge in solid dosage forms, parenteral technology, biologics or combination products
- Knowledge of compendial and cGMP requirements, FDA regulations and the ability to interpret and apply them
- Proficiency with the use of global systems (e.g., Systems, Applications and Products (SAP), Document Control and Archiving (DCA)).
- Good verbal and written communication skills essential
- Excellent interpersonal skills
- Capable to manage multiple priorities
- Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirement are met
- Trained in auditing techniques and skills such as observation, questioning, and assessment of complex problems
Job Description:
- Manages CMO relationships from a quality and compliance perspective, including monitoring quality metrics, performing annual risk assessment of CMOs and executing oversight as defined by Standard Operating Procedures (SOP s), authoring and executing Risk Mitigation Plans as needed
- Determines disposition of drug products according to Client and regulatory specifications and standards
- Review change requests generated internally or by External Manufacturer
- Reviews Annual Product Quality Reviews (APQR s) authored by Contract Manufacturers/Packagers and supplement APQR s as required
- Investigate and/or evaluate manufacturing, packaging and laboratory deviations or incidents and associated Corrective and Preventive Actions (CAPA s) and provide direction and recommendations as to future course(s) of action
- Review Quality Agreements
- Review and approve product quality complaint investigations
- Review and approve validation/qualification protocols and reports from the External Manufacturer as defined in related Quality Agreements
- Write, review and implement SOP s to ensure compliance with current Client standard and current Good Manufacturing Practices (cGMP)
- Participate as required on Fact Finding Investigation Team (FIT and Fact Finding Investigation Review Meetings (FIRM)
- Supports product recalls and executes plan as assigned
- Represent Client during FDA/other regulatory inspections and corporate GMP compliance audits as defined in related Quality Agreements
- Assist with preparation of audit observations
- Participate in audits (For Cause) of North American External Manufacturers of drug products ensuring compliance with all appropriate Client and FDA and European Medicines Agency (EMA) cGMP regulations and policies
- Represent Quality on cross-functional teams within the "Virtual Manufacturing Plant", Technical Transfer teams, Supplier Selection, Serialization Manufacturing and Packaging launch teams
This 12+ Month Position starts ASAP
ALPHA S REQUIREMENTS 24-07128
MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEE
-
Clinical Quality Assurance Specialist
1 week ago
New York, United States Center for Alternative Full timeJob DescriptionJob DescriptionJob Title: Clinical Quality Assurance SpecialistJob Summary: CASES is looking for a clinical quality assurance specialist to join the team working with the mental health treatment programs. The ideal candidate is experienced in the standards of care and regulations administered by the New York State Office of Mental Health...
-
Senior Quality Assurance Specialist
Found in: Resume Library US A2 - 2 days ago
East Syracuse, New York, United States SGS Full timeJob Description Our East Syracuse, NY laboratory is looking for a Senior Quality Assurance Specialist to join their team! The Senior Quality Assurance Specialist is responsible for aspects of data quality, integrity oversight, and for ensuring quality systems are functioning within QSM requirements and regulatory compliance, corrective action...
-
Quality Assurance Specialist Trainee with OPT
Found in: beBee S US - 3 weeks ago
New York, United States ITJobsList Full timeOur Client is actually focused on offering the students with secure unpolluted transportation. OPT is actually charged with administering all administrative and operational features through the workplace.The Quality Assurance Specialist Trainee will probably be taught to examine the quality of transportation solutions we offer to the students Performs...
-
Quality Assurance Specialist Trainee with OPT
Found in: beBee jobs US - 3 weeks ago
New York, New York, United States ITJobsList Full timeOur Client is actually focused on offering the students with secure unpolluted transportation. OPT is actually charged with administering all administrative and operational features through the workplace.The Quality Assurance Specialist Trainee will probably be taught to examine the quality of transportation solutions we offer to the students Performs...
-
Quality Assurance Specialist
Found in: beBee jobs US - 3 weeks ago
New Ulm, Minnesota, United States Firmenich Full timeQuality Assurance SpecialistNew Ulm, MN, USOn-Site S13 The Quality Assurance activities at a site in line with Global driven Policies and Procedures. At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers & Communities and driving...
-
Senior Quality Assurance Specialist
Found in: Appcast Linkedin GBL C2 - 8 hours ago
New York, United States X4 Life Sciences Full timeA long term partner of X4 Life Sciences is looking to add a Senior Quality Assurance to it's rapidly growing team. Our client are a global leader in medical biotechnologies, specializing in cellular therapies, manufactured in the USA, and are currently operating out of Brooklyn, NY.Position Overview:As a Senior Quality Assurance Specialist, you will play a...
-
Senior Quality Assurance Specialist
Found in: Appcast US C2 - 14 hours ago
New York, United States X4 Life Sciences Full timeA long term partner of X4 Life Sciences is looking to add a Senior Quality Assurance to it's rapidly growing team. Our client are a global leader in medical biotechnologies, specializing in cellular therapies, manufactured in the USA, and are currently operating out of Brooklyn, NY.Position Overview:As a Senior Quality Assurance Specialist, you will play a...
-
Manufacturing Quality Assurance Associate
4 days ago
New Hanover County Airport, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Manufacturing Quality Assurance Associate
Found in: Jooble US O C2 - 3 days ago
New Hanover County, NC, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of Manufacturing Quality Assurance Associate. This position, in the Manufacturing Quality Assurance department, requires a Bachelor’s degree or higher in a scientific or engineering discipline...
-
Clinical Quality Assurance Specialist
1 week ago
New York, United States Center for Alternative Full timeJob DescriptionJob DescriptionOverview:CASES is looking for a clinical quality assurance specialist to join the team working with the mental health treatment programs. The ideal candidate is experienced in the standards of care and regulations administered by the New York State Office of Mental Health (OMH), NYC Department of Health and Mental Health...
-
Sr./Specialist, Quality Assurance
1 week ago
New York, United States AmplifyBio Full timeAre you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio ! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO...
-
Sr./Specialist, Quality Assurance
Found in: Appcast Linkedin GBL C2 - 2 weeks ago
New Albany, United States AmplifyBio Full timeAre you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO...
-
Sr./Specialist, Quality Assurance
Found in: Appcast US C2 - 2 weeks ago
New Albany, United States AmplifyBio Full timeAre you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D work, a preclinical CRO...
-
Quality Assurance Associate
4 days ago
New Hanover County Airport, United States Quality Chemical Laboratories Full timeQuality Chemical Laboratories (QCL), a leading Pharmaceutical testing and manufacturing laboratory in Wilmington, is seeking a qualified candidate for the position of QA Associate – Report Generation. The candidate will be responsible for review and approval of reports generated from laboratory data, such as certificate of analysis and stability study...
-
Food Safety Quality Assurance Associate
1 week ago
New York, United States LHH Full timeWe’re looking for an enthusiastic and self-motivated Food Safety Quality Assurance Specialist (FSQA) to join one of our fantastic client's team. In this role you will: Work in a dynamic environment with a chance to make an impact Develop lasting relationships with great people Have the opportunity to build a satisfying career About our benefits: Medical,...
-
Food Safety Quality Assurance Associate
2 weeks ago
New York, United States CareerBuilder Full timeWere looking for an enthusiastic and self-motivated Food Safety Quality Assurance Specialist (FSQA) to join one of our fantastic client's team. In this role you will: Work in a dynamic environment with a chance to make an impact Develop lasting relationships with great people Have the opportunity to build a satisfying career About our benefits: Medical,...
-
Quality Assurance Specialist
Found in: beBee S US - 3 weeks ago
New Ulm, MN, United States Firmenich Full timeQuality Assurance Specialist New Ulm, MN, US On-Site S13 The Quality Assurance activities at a site in line with Global driven Policies and Procedures. At dsm-firmenich, being a force for good is not optional. Diversity, Equity & Inclusion is a shared responsibility woven into our daily work, benefiting to our People, Customers &...
-
Sr./Specialist, Quality Assurance Operations
2 weeks ago
New Albany, United States Amplifybio, LLC Full timeJob DescriptionJob DescriptionAre you passionate about significantly improving the future of medicine? Do you believe that people are the most important asset of any company? If so, join AmplifyBio! AmplifyBio is a leading contract research organization with a comprehensive range of services that span from being an outsourcing partner for discovery stage R&D...
-
Quality Assurance Manager
2 weeks ago
New York, United States Schreiner Group Full timeSchreiner Group LP has a full-time regular position for a Quality Assurance Manager. RESPONSIBILITIES:· Coaches, mentors, and leads all employees in the Quality Assurance Manager’s areas of responsibility to achieve goals and objectives related to quality control, quality assurance, customer demands, and customer specifications.· Drives quality...
-
Director of Quality Assurance
1 week ago
New York, United States CIS Secure Full timeCIS Secure Computing serves the secure communications market as a leading provider of communications and computing solutions for government and commercial customers. CIS designs and manufactures a wide range of products, which include secure telephones (under the TSG protocol), secure computers (TEMPEST), encrypted tactical communication systems, secure...