Medefil, Inc.
Quality Control Analyst
Job Description
Location: Glendale Heights, IL
Reports to: Quality Manager
Department: Quality
Level/FLSA: Exempt
Position Summary: Reporting to the Manager of Quality, the Quality Control Analyst is responsible for the following, but not limited to:
Key Responsibilities include:
• Perform sampling and microbiological or chemical testing of raw materials, in-process and finished products following laboratory test methods as required.
- Perform all Quality Control laboratory activities using current approved analytical methods.
- Perform all required testing associated with protocols and studies (e.g., Cleaning validation rinsate samples, investigation samples), new product launches and development projects.
- Perform method development, transfer, verification and validation activities independently or under management direction.
- Perform sampling and testing of water system.
- Perform standardization of all required reagents and solutions.
- Communicate testing results and disposition to QC Supervisor as required.
- Ensure that adequate laboratory supplies, equipment and materials are maintained to avert any delays or testing interruptions.
- Perform sample log in as needed.
- Perform daily verification checks of lab equipment such as balances and pH meters.
- Perform retain sample area inventory recording, inventory management under senior analyst directions.
- Responsible for monitoring and logging of laboratory chambers.
- Support data generation and trending of all testing performed.
- Develop and establish appropriate statistical analysis techniques as needed.
- Participate in NOE, OOS, NCR, CAPA and Deviation investigations as needed.
- Maintain accurate records per cGMP's and applicable international standards.
- Comply with cGMP and applicable international standards and regulations and safety procedures.
- Comply with established Quality Management System procedures and company policies.
- Support all internal and external audits.
- Be flexible and support departmental needs, as and when necessary.
- Perform other duties as assigned.
Minimum Education and Experience Requirements
- B.S or M.S in pharmaceutical sciences, chemistry, biology, or related field.
- Microbiological and wet chemistry testing.
- Laboratory analytical instrumentation operation.
- Knowledge of aseptic technique.
- Good organizational, communication, teamwork, and interpersonal skills
- Excellent attention to detail
- Good verbal and writing skills in communicating technical information.
- Proficient in Windows based software such as Word and Excel.
- Quick learner of hands-on techniques.
- Deliver work in set timelines as per supervisor's instructions.
Medefil, Inc. is an equal opportunity employer. It is the policy of Medefil, Inc. to afford equal employment opportunities regardless of employees or job applicants "actual or perceived" race, color, religion, national origin, ancestry, age, sex, marital status, order of protection status, disability, military status, sexual orientation, pregnancy, or unfavorable discharge from the military.
Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible spending account
- Health insurance
- Life insurance
- Paid time off
- Vision insurance
Shift availability:
Ability to Commute:
- Glendale Heights, IL 60139 (Required)
Ability to Relocate:
- Glendale Heights, IL 60139: Relocate before starting work (Required)
Work Location: In person
