Fleming Pharmaceuticals, based in the greater St. Louis area, is a privately held company specializing in the development and manufacture of innovative prescription and over-the-counter therapies. Our fully-integrated Missouri facilities house liquid and solid dose manufacturing and packaging, analytical microbiological laboratories, research and development, distribution, marketing and business administration functions.

Primary Responsibilities:

·         Batch record issuance/review and product release activities to ensure all products released meet company/regulatory standards and customer expectations

Job Responsibilities, may include but not limited to, the following:

·         Assemble and Issue batch records for use from approved master copies

·         Review completed batch records, including all manufacturing, packaging, inventory and laboratory records to confirm product conformance prior to release into distribution

·         Keep Quality Assurance Manager informed of any problems that are likely to affect the integrity of an operation (i.e., have an impact on GMP compliance)

·         Perform inspections of incoming materials per approved specifications

·         Assist in development and implementation of quality systems and procedures

·         Interact on department’s behalf to assist and direct the completion of Nonconformance investigations

·         Assist in development of client-related documentation (batch records, documentation supporting submissions, etc.)

·         Conduct vendor audits, including preparation of audit reports and all follow-up activities as required

·         Other duties which may be assigned from time to time by the QA Manager

Job Requirements (Educational/Technical):

·         Minimum Education: Bachelor’s degree in Biology, Chemistry or related discipline

·         Knowledge of Federal regulations (i.e., cGMPs, 21CFR parts 210 and 211, etc.)

·         Minimum 2 years experience in a regulated environment, preferably in Quality Assurance or Quality Control preferred

Skill Requirements:

• Strong interpersonal and communication skills
• Strict attention to detail, statistical and analytical capability, and ability to troubleshoot issues
• Strong computer skills: proficient with databases and Microsoft Office software
• Strong organizational skills with ability to manage large quantities of documentation and data and prioritize multiple projects; detail oriented

Physical Requirements:

·         Lifting of approximately 30 pounds unassisted.

Work Environment:

·         Office, Warehouse and Production Environment.

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification.  They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.

At Fleming we constantly invest in our employees, enabling them to develop their full potential.  With clear career paths in an exciting workplace, we generate opportunities for professional advancement in all areas of the company.  Fleming’s employment policies reflect core values of respect, integrity, and the pursuit of excellence.  We embrace the diversity of all individuals and incorporate the letter and spirit of Equal Opportunity Employment. EOE