Quality Assurance Associate in Cockeysville, MD at Apex Life Sciences

Date Posted: 6/6/2018

Job Snapshot

Job Description


Client in the Hunt Valley area seeking QA Associate!!!

BASIC FUNCTION: Audits in process and finish product batch production and packaging records for conformance to company established procedures and government regulations and insurance conformance to internal Standard Operating Procedures (SOPs) and government regulations prior to product release. Reports non-conformances to the appropriate personnel for reconciliation. Ensures the safety, identity, strength, purity and quality of the products while supporting the overall company business plan.

RESPONSIBILITIES:

Review and approve batch record documentation and related material in accordance with SOP‘s and other statutory governing regulations in order to expedite and execute product release.

Initiates correction of errors and omissions, and assist in performing product investigation,i.e., component reconciliation, as required

Respond to client observations relating to executed batch records reviewed.

Assist in performing investigations involved with batch record reviews and wall materials, as required

Issue “Release”, “Hold”, and/or “Rejected” Status Labels, as required and applicable 

Initiate product resampling and finished product release “re-stickering”, as required

Review Quality Assurance(QA) paperwork for correctness to be incorporated in the batch record

Performs “Finished Product Review” of batch records to ensure that all “Line Clearance”, “Weighing Sheets”, Room and Equipment Labeling/Status Indicators, packaging components, etc., are present, signed, and delete it, along with corresponding quality insurance inspection paperwork

Ensures that any events deviations , investigations, Out-of-specifications (OOS) Reports, as they relate to the batch are identified and addressed in a timely and accurate manner.

Review Analytical Laboratory Reports the raw materials, in process materials, and finished product, ensuring that all have been properly signed, verified, and approved, as per SOP‘s

Prepare and submit Annual Product review (APRs) is all commercial Pii products

Perform data trending and analysis, as assigned

Other duties as assigned

REQUIREMENTS:

A background in cGMP Compliance within the pharmaceutical, biologics, and/or medical device manufacturing industry, is required. 

Bachelors Degree, preferably in the Life Sciences, Chemistry, Physics

TWO (2) to three (3) years’ experience and Quality Assurance in a cGMP-regulated industry

Experience in writing and maintaining cGMP documentation

Ability to analyze data/information and to assess and resolve complex programs is required

Must have strong computer skills and should be familiar with programs such as MS Word, Excel, PowerPoint, Access, Projects, etc. 

Must have strong communication and interpersonal skills

Must have the ability to multitask and meet critical deadlines must show strong initiative and “can do” attitude

Must have the ability to work with and effectively communicate with cross-functional teams

Ability to effectively train other individuals to programs and procedures