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Quality Assurance Specialist (Batch Release)

Quality Assurance Specialist I, Batch Release

 


Those who join our client feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

Position:                   QA Specialist I                                                                                                                          

Position Summary:

Participate in the execution of long-range goals, strategies, plans and policies as they relate to the management of quality systems for the cGMP operations.  This position is responsible for performing one or more of the following: performing review of records for batch release, visual over-inspection of filled products, ancillary cGMP record reviews, raw materials and product release, release and verify products for Distribution Center, and in-process audits.

Essential Duties and Responsibilities:

Raw Material Release

 

Confirm receipt of raw materials and API
Develop and revise raw material testing specifications
Determine raw materials and API testing requirements via the following:

 

a.  Compendial

      b.  Client specific

Vendor qualification related

 

Provide documented requirements for testing and provide pre-determined specifications
Review, evaluate and approve test results to disposition materials for use in the manufacturing process
Disposition raw materials and API include the following:

 

Label raw material and API indicating status, expiration data, etc.
Filing of raw material release documentation
Maintenance of the component release database
Release raw materials in iREN MRP System.

 

 

Distribution Center

 

Confirm receipt of products designated for Distribution Center
Develop and revise product specifications
Review and evaluate all paperwork to disposition products for shipping.
Disposition products include the following:
Label indicating correct status, expiration data, lot #, etc.
Filing release documentation

Filing shipping documentation

 

Batch Review

Responsible for review of executed batch records for compliance with current CBL SOPs and GMP requirements
Performs compiling and copying of executed batch records
Performs delivery of dispositioned batch records to clients
Ensures that executed batch record sections submitted to QA are secured prior to disposition
Conducts batch record review meetings as required
Conducts internal audits for the manufacturing process

Regulatory Support

Provide support for yearly updates for regulatory documentation
Participate in Regulatory Agency Inspections

General Responsibilities

Data and documentation review and analysis
Performs over-inspection process of finished product
Responsible for timely completion of final product shipping authorization documentation
Participate in on-the-floor manufacturing process as it relates to document review, filling, packaging and shipping operations according to Quality Assurance procedures
Performs on the floor audits of warehousing operations according to Quality Assurance procedures
Perform internal audits

Supervisory Responsibilities:

None

Competencies:

 Communication—the individual speaks clearly and persuasively in positive or negative situations, demonstrates group presentation skills and conducts productive meetings.
Planning/Organizing—the individual prioritizes and plans work activities, uses time efficiently and develops realistic action plans.
Adaptability – Maintains effectiveness when experiencing major changes in work tasks or the work environment; adjusting effectively to work within new work structures, processes, requirements, or cultures.
Customer Focus—Making customers and their needs a primary focus of one’s actions; developing and sustaining productive customer relationships
Decision Making—Identifying and understanding issues, problems and opportunities; comparing data from different sources to draw conclusions; using effective approaches for choosing a course of action or developing appropriate solutions; taking action that is consistent with available facts, constraints, and probable consequences.

Desired Minimum Qualifications
Education and Experience:

BS in Chemistry/Biology or related discipline with 0 to 2 years Quality Assurance experience

 

Necessary Knowledge, Skills and Abilities:

 

Must have strong attention to detail
Ability to manage multiple priorities and tasks in a dynamic environment
Excellent written and verbal skills
Ability to exercise judgment to determine appropriate corrective actions
Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions
Ability to use computer programs
Ability to work in a team environment
Knowledge of cGMP

 

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