Quality Assurance Specialist Position Available In Rockland, New York

Quality Assurance Specialist 3.9 3.9 out of 5 stars 7 Corporate Drive, Orangeburg, NY 10962 Determines disposition of final product and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and PBA Standard Requirement Documents.

Duties:

Prepare or maintain technical files as necessary to obtain and sustain product approval. Review and approval of data for determining the disposition of GMP material (raw material, in-process, finished product, packaging, labeling and manufacturing components). Perform Quality Assurance issuance, review and approval of production and development batch records and documents. Assign QA release status and disposition to approved finished products. Generate historical data analysis of test results for the Production and Quality process. Generate metrics that reflect the improvements of the batch record review process. Support continuous improvements and training efforts as a result of trend analysis performed following batch record reviews. Develop and document training plans based on Regulatory, customer, and company requirements and specifications. Review and approval of SOPs, Specifications, Deviation Reports, Change Controls, OOS’s/OOT’s and Test Methods. Develop and implement comprehensive technical documentation to ensure compliance with industry standards and regulations. Review laboratory protocols and reports for accuracy and compliance to cGMP’s/GLP’s, as applicable. Update and maintain QA database for retrieval of reports. Monitor testing procedures to ensure that all tests are performed according to established item specifications, standard test methods, and protocols. Record, evaluate, and document results and compare them to expected results. Prepare and reports analyzing data obtained from customer/consumer-reported cases. Serve as a backup correspondent for calls throughout the lifecycle of a caller’s request, including follow-ups with the escalation team. Identify consumer/customer needs, research issues, resolve complaints/adverse events/inquiries, and provide solutions as necessary. Qualifications; B.S. in Engineering, Quality experience preferred Experience with CFR Regulations, cGMP Regulations and FDA Environment (Food or Pharmaceuticals) preferred Mechanical aptitude desired. Excellent interpersonal skills Must have good English written and verbal communication skills Good arithmetic skills are required

Job Type:

Full-time Job Type:

Full-time Pay:

$60,000.00 – $65,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Referral program Vision insurance

Schedule:

8 hour shift Monday to

Friday Work Location:

In person