Enable America Jobs

(Weekend Shift) Friday – Sun 7:00am to 7:30pm

Every other Monday 7:00am to 3:30pm, Pay Range: DOE

Job Summary:

• Perform QA functions as needed

• Responsible for checking and verifying that the product is made in accordance with the production records, regulatory requirements and applicable SOPs and evaluate the quality of each product

Duties and Responsibilities include but are not limited to:

• Monitor processing/packaging conditions to assure cGMP compliance to specifications (SOP’s)

• Perform Quality Assurance activities as defined in SOP’s (i.e. line startup and line clearance)

• Perform AQL checks to confirm product meets quality attributes

• Monitor and document results of quality tests and inspections as required (i.e. torque testing, liquid levels, pill/capsule counts, vacuum testing, pH testing)

• Perform allergen testing for production areas

• Perform batch record reviews

• Provide transfer approvals for production

• Verify quantities of finished product for encapsulation

• Verify labels prior to use in packaging

• Communicate significant issues or developments identified during work activities and provide recommended process improvements to QA Supervisor/Manager

• Coach production operators on quality requirements

• Provide on the floor support to manufacturing operations

• Assist in performing investigations

• Assist in preparing for internal audits

• Maintain all SOP’s relevant to current position

• Complete projects and other duties assigned by QA Supervisor/Manager

Knowledge, Skills, and Abilities:

• Working knowledge and understanding of current Good Manufacturing practices for the Dietary Supplement industry

• Knowledge of 21 CFR 11 a plus

• Proficient in MS Office (Excel, Word, Outlook, PowerPoint)

• Ability to communicate at all levels of the company pertaining to manufacturing and laboratory activities

• Strong math and analytical skills

• Must display strong interpersonal skills, along with strong organizational abilities

• Must be detail oriented

• Strong technical writing and documentation skills

• Must be a self-starter who is able to work independently

• Ability to multitask and work under pressure to produce positive outcomes

Qualifications

Education:

• High School diploma

• Bachelors of Science in Biology, Chemistry. Biochemistry or related field or 5 years’ experience relevant

Experience

• Previous experience in manufacturing in a GMP setting

• At least 2 years’ experience in Quality Control or Quality Assurance in an herbal, dietary supplement or pharmaceutical industry

Physical:

• Requires standing for long periods of times

• Ability to lift 50 lbs.

Performance Measurements:

• Attendance and promptness

• Meeting quotas and goals

• Following appropriate SOP’s and department procedures.

• Making recommendations and improvements

• Dependability