Quality Control/Assurance Specialist

MedisourceRx is looking for a Quality control/ Assurance Specialist at our Los Alamitos 503b outsourcing facility. This position in the Quality Unit supports quality and pharmaceutical manufacturing operations and is responsible for, but not limited to, environmental monitoring, material transfer, chemical inventory control, analytical test tracking, document distribution and completions, and other quality tasks.

As part of the quality unit, the Quality control / Assurance Specialist is also responsible for ensuring cGMP compliance in documentation, applicable department programs and initiatives including training.

Core Responsibilities:

· Visually inspect products for the presence of defects such as container-closure damage, turbidity, presence of particulates, and other non-conformances

· Read environmental monitoring plates daily for colonies

· Receive and release materials from warehouse

· Verify bubble point for filter integrity testing

· Ensure line clearance of products

· Create release testing sample submission forms and send samples to contract testing laboratories

· Participate in labeling activities, which may include creating labels, printing, verifying label accuracy, affixing labels to products or outer packages, and/or examining finished products for label defects

· Ensure batch records and logs are completed and accurate, reconcile mistakes and issues when needed

· Monitor temperature, relative humidity, and pressure differential data (print reports, note anomalies, and alert Quality Manager and Pharmacist-in-Charge.

· Prepare trending reports for environmental monitoring and alert Quality Manager and Director of Operations of any alert limit excursions

· Execute, update, and provide recommendations for Standard Operating Procedures

· Document control and security, including scanning COAs, logs, calibration/certification reports, and batch records, paper-based files archiving and storage, electronic file organization

Other Responsibilities:

· Review and sign off on records and logs

· Participate in continuous improvement by process review, documentation updating and implementation

· Shipping related activities, such as checking orders for accuracy when needed

· Support audit ready environment and assist during federal and state audits with document retrieval and related tasks

· Work closely with manufacturing and shipping departments for training, validation, documentation, and other related activities

Job

· Or high school diploma/GED with 1-2 years’ experience in quality control, pharmaceutical manufacturing, or related

· 20/20 vision (either corrected or uncorrected) with no color-blindness

· Wear personal protective equipment and work in controlled environments as necessary

- Be able to lift up to 50lbs

Desired Knowledge:

· Experience/knowledge of FDA regulations for pharmaceutical manufacturing/compounding at a 503b outsourcing facility is a plus

· Knowledge and/or experience in cGMP, FDA 21 CFR parts 210 and 211, and USP guidelines is a plus

Desired Qualities:

· Ability to learn and adapt new ideas

· Ability to follow instructions and adhere to standard operating procedures

· Good observation skills and attention to detail

· Should be able to perform repetitive work while visually inspecting

· Continuous improvement mentality

· Ability to work in a dynamic and fast pace environment

· Ability to juggle multiple tasks

About MedisourceRx:

MedisourceRx is an FDA registered 503b outsourcing facility based in Los Alamitos, California. Our mission is to provide the highest quality medications to healthcare providers that achieve excellent clinical outcomes and uphold patient safety. In addition, we are experienced with the production of medications used in clinical trials. We adhere to the stringent cGMP procedures and USP <797> requirements put forth by the FDA under the new 503b guidelines. Our processes ensure our products are appropriately potent, sterile, and endotoxin free.

Job Types: Full-time

Salary: $20-$28 per hour

Expected hours: 40 per week

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 1-2 year

Schedule:

• Monday to Friday

Work setting:

• In-person
• Manufacturing facility
• Office
• Los Alamitos, CA 90720: Relocate before starting work (Required)

Work Location: In person