Quality Assurance Specialist
18 hours ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at TekWissen Group. As a Quality Assurance Specialist, you will be responsible for ensuring the quality of clinical products processed through primary and secondary packaging, warehouse, and distribution operations.
Key Responsibilities:- Apply Good Manufacturing Practices (cGMP) in all areas of responsibility.
- Demonstrate and promote the company vision.
- Perform approval of specifications and incoming inspections on material (i.e. drug, components) and distribution shipments.
- Perform material and process inspections and samplings.
- Participate in continuous improvement initiatives and assist with root cause investigations for nonconforming issues.
- Author, revise, and comply with all relevant SOP's and Work Instructions and properly document activities when necessary.
- Resolve and assure that issues potentially affecting product quality/compliance are escalated to the attention of the Team Leader and/or Management.
- Assure that issues are resolved in a timely manner and corrective actions are implemented accordingly.
- Perform all activities in a safe and efficient manner.
- Associates degree or High School Diploma with 2 years of experience.
- A minimum of 1 year of experience in Pharmaceutical or of a related, regulated industry and a high school diploma.
- Familiar with Quality Systems (Change Control, deviations, complaint management, documentation management, among others).
- Must be able to work in a refrigerated environment (35F to 46F) with provided protective wear.
- Must be able to work in a freezer (-20F) environment with provided protective wear.
- Must be able to work in potent compound suites with provided protective wear (PPE).
- Good reasoning and problem-solving skills, basic math skills, good communication skills, basic computer skills.
- Must be willing to work various shifts and overtime depending on business needs.
- Must be able to work independently.
- Mastery of skills required to read, understand, and adhere to the SOPs and policies of a GMP environment.
- Must not be allergic to penicillin or cephalosporin products.
- Extensive standing and walking on packaging floor in order to monitor room activities.
- Work schedule, Monday through Friday, 8 hours per day. Additional overtime and weekend (Saturday or Sunday) work may be required.
- This position requires standing, bending and lifting. Exerting and lifting up to 25lbs of materials occasionally, and 10lbs of materials regularly.
- The position is exposed to cold temperatures for more than one hour at a time.
- The position is exposed to -20F temperatures for at least 15 minutes at a time.
- The position will be exposed to atmospheric conditions could require special personal protection equipment.
- Incumbent must meet applicable visual acuity/color blindness standards to perform visual inspections in a cGMP environment
TekWissen Group is an equal-opportunity employer supporting workforce diversity.
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