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Actalent
Lancaster
The Quality Assurance Auditor reports to the Director of Quality. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identified. Roles
Job Source: ActalentActalent
Lancaster
QA Auditor The Quality Assurance Auditor reports to the Director of Quality. This role is responsible for developing and maintaining a strong Internal Compliance program ensuring compliance to applicable regulations. The QAA is required to perform internal and external audits, prioritize audit schedules and corrective actions to the findings identi
Job Source: ActalentActalent
Lancaster
Job Title: Formulation ScientistJob Description Seeking a skilled Formulation Scientist capable of supporting and leading moderately complex formula development, reformulation, and process improvement across a variety of forms including powders, tablets, capsules, soft chews, pellets, and liquids. The ideal candidate will cooperate with Product Dev
Job Source: ActalentWendy's
Mint Hill, NC, United States
Our Grill Operators maximize the guest experience and taste of our food by cooking small batches of products, several times during the shift, ensuring freshest and juicy food all day. Assist management in achieving and maintaining outstanding interior and exterior restaurant cleanliness. As a Wendys team member, your restaurant will support you wit
Job Source: Wendy'sWendy's
Indian Trail, NC, United States
Our Grill Operators maximize the guest experience and taste of our food by cooking small batches of products, several times during the shift, ensuring freshest and juicy food all day. Assist management in achieving and maintaining outstanding interior and exterior restaurant cleanliness. As a Wendys team member, your restaurant will support you wit
Job Source: Wendy'sWendy's
Monroe, NC, United States
Our Grill Operators maximize the guest experience and taste of our food by cooking small batches of products, several times during the shift, ensuring freshest and juicy food all day. Assist management in achieving and maintaining outstanding interior and exterior restaurant cleanliness. As a Wendys team member, your restaurant will support you wit
Job Source: Wendy'sATI
Monroe
**Position** : Chemistry Lab Technician **Location** : Monroe, NC **Requisition ID:** : 24-2615 **Proven to Perform.** From the edges of space to the bottoms of ocean, our materials are proven to perform -- and so is our team. We're hiring high performers as proven as our products. Join us. SUMMARY: Prepare testing specimens and perform analytical
Job Source: ATIClinLab Staffing
Monroe, NC, United States
Microbiology Manager Monroe, NC Full-Time, Permanent Overview The Microbiology Manager reports to the Associate Director / Director, Microbiology. The primary responsibilities are to manage and coordinate staff performing microbiological testing, support the manufacturing of aseptically process and terminally sterilized pharmaceutical products. Pr
Job Source: ClinLab StaffingMonroe
Batch Release Reviewer
Department: Batch Release
Location: Monroe, NC
START YOUR APPLICATION (rmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3097309&source=3097309-CJB-0)
Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
Glenmark Pharmaceuticals Ltd. employs over 10,000 people in more than 60 countries, including twelve manufacturing facilities, five R&D centers, and front-ends in the US, EU, India, and Brazil.
Currently, Glenmark is in a phase of immense growth both in the U.S. and abroad, and is well-positioned to successfully emerge as a leading integrated research-based pharmaceutical company.
Position Summary:
The Quality Assurance Batch Record Reviewer is primarily responsible for:
+ Collaborating with Manufacturing Operations for compliance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDPs)
+ Promptly and accurately reviewing batch production records (BPRs), Quality Control records, and all logs to determine compliance with Good Manufacturing Practices, Good Documentation Practices, and established company procedures.
Major Functions and Responsibilities:
+ Promptly and accurately review manufacturing batch records and identify product records that do not meet product release requirements.
+ Identify and resolve batch record documentation errors in a timely manner
+ Support change control, deviation, issue, incident, investigation and CAPA related to batch manufacturing
+ Support quality system improvements
+ Prepare release labels for manufacturing and packaging operations
+ Review laboratory data for completeness and compliance to specifications
+ Archive all manufacturing records, quality control records, and logs once products are released
+ Review certificates of analysis, certificates of conformance, etc
+ Release all products that meet specification requirements manufactured onsite
+ Provide support during regulatory and other audit-related activities
+ Assist in the data collection, summary preparation and submission of periodic metrics
+ Perform other duties as assigned by Director of the department
Required Education / Work Experience:
+ Minimum 3-5 years of experience in a cGMP regulated environment (pharmaceutical, medical device etc)
+ Bachelor-s Degree or equivalent work experience
+ Prior batch record review experience is required
+ Microbiology and/or Chemistry experience is preferred
+ Manufacturing and/or Operations experience is preferred
+ Ability to work directly with manufacturing under limited supervision is required
Other Skills and Abilities:
+ Self-starter, motivated individual with high level of attention to detail
+ Able to work effectively and efficiently toward goal completion in a complex, diverse environment with multiple and changing demands
+ Strong interpersonal skills and ability to work with all levels of the organization
+ Strong problem solving ability. Ability to clearly express ideas (verbal and written) ability to translate verbal and written instructions
+ Demonstrated knowledge of computer and quality management systems and Microsoft office skills required
START YOUR APPLICATION (rmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3097309&source=3097309-CJB-0)
Email Alert for Batch Release Reviewer_ jobs in Monroe
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