1001 Durham Ave South Plainfield, NJ 07080 | 908.941.5456

PuraCap
QA Specialist

Career Opportunities

 

 

We are looking for talented and dedicated individuals for our team. If great ideas inspire you, perhaps there’s a place for you at PuraCap. You’ll enjoy a challenging environment, terrific colleagues and all the opportunities your drive and initiative can handle.

 

Find out more about career opportunities & PuraCap Pharmaceutical on our LinkedIn Page

 

POSITION DESCRIPTION

QA Specialist

 

I.     JOB SUMMARY

PuraCap Pharmaceuticals is an exciting, growing company with an established footprint in the manufacture and distribution of OTC pharmaceutical products as well as topical prescription medications.

 

II.   JOB DUTIES AND RESPONSIBILITIES

 

1)     Initiate and follow-up with the customer complaints and adverse events investigation process. Monitor internal reports to ensure that complaints/adverse events are thoroughly documented, investigated, assessed, proper corrective action is taken and tracked to completion.
2)     Initiate the investigation process for out-of-specification results and process/product deviations. Monitor internal reports to ensure that deviations are thoroughly investigated, documented, proper corrective action is taken.
3)     Coordinate product recall process including root cause analysis, validation and verification of corrective actions, establishing permanent preventive actions such as revising procedures and associated documents, training of personnel.
4)     Coordinate Mock recall actions, perform traceback procedures, acquire records and supporting information, reconcile the affected product with current inventory.
5)     Responsible for submission of documented substantiation evidence to support Potential New Item (PNI) and Label Claim Substantiation (LCS) processes for new product launches.
6)     Perform final review and approval of labeling and packaging artwork for new products and revision to previously approved labeling.
7)     Review and approve internal drug facts documentation created to reflect any changes implemented by national brand products.
8)     Conduct reviews of CMO batch release documents to ensure products are manufactured and packaged according to established company’s specifications.
9)     Monitor CMO’s investigation reports to ensure that CAPAs, deviations and out-of-specification results are thoroughly investigated, proper corrective action is taken and tracked to completion.
10)  Responsible for review and approval of packaging specifications to support new product launches.
11)  Responsible for creation of print mats for new and existing products to support new product launches.
12)  Conduct site audits of a contract organizations to assure that the packaging, control of the operations, and a document system are in cGMP compliance. Review documentation, prepare the finding/recommendation and final audit reports.
13)  Review and approve CMO manufacturing equipment validation documentation.
14)  Review and approve CMO product stability protocols and monitor the stability reports.
15)  Generate SOP testing documentation for the employee training and assure of its delivery and completion by the impacted departments.
III. WORK LEADERSHIP OR SUPERVISION 

Approximate number of direct reports: 1

 

Approximate number of indirect reports: N/A

 

PuraCap Pharmaceutical LLC is an equal opportunity employer and affords equal opportunity to all applicants and employees for all positions without regard to race, color, religion, gender, national origin, age, disability, veteran status, or any other status protected under local, state, or federal laws.

 

If interested in applying for any of the above positions at PuraCap, please send your Resume / CV to humanresources@puracap.com