Job Details

Located: Salisbury, MD

Quality Assurance Lead for 3rd shift

• Headquartered in Salisbury, Maryland, Inc. is a noted, top 10 fastest growing generic pharmaceutical company in the United States.
• Vertically integrated with the parent company (Jubilant Life Sciences) in India, Cadista applies its local market expertise and technical capabilities to all forms of solid dose products to enhance patient outcomes.
• Cadista employs approximately 300 employees and generates approximately 100MM in annual revenue.
• The site is uniquely located on the Eastern Shore within 30 minutes east of beautiful Ocean City, Maryland and the same to the Chesapeake Bay to the west. For more information, visit www.cadista.com.

• The QA Associate Lead performs independent inspections of process rooms, equipment, materials, etc. before initiating the manufacturing/packaging process.
  
• Monitors the product quality through periodic in-process testing during various stages of processing, and ensures compliance with all cGMP /SOP requirements.

• Essential functions, as defined under the Americans with Disabilities Act, may include the following tasks, knowledge, skills and other characteristics.
  
• This list of tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class.
• It does not imply that all positions within the class perform all of the duties listed, nor does it necessarily list all possible duties that may be assigned.)
• Provides guidance to assigned QA Associates in their daily routine and assigns job tasks as needed.
• Serves as a resource to production regarding quality issues and provides resolution for minor quality issues and major quality issues (with guidance from Quality Management).
• Communicates quality related issues to management in day shift.
• Acts as first responder for Production deviations.
• Works closely with the Manufacturing and Packaging Management to assure the appropriate immediate actions and corrective actions are taken for deviation.
• Trains shift personnel on SOPs and Work Instructions.
• Performs inspections and releases of recently cleaned equipment and rooms.
• Inspects labels, labeling materials and verifies raw materials prior to use by production.
• Maintains quarantine/release/reject system for raw materials, labeling materials, and finished drug products.
• Conducts in-process testing on drug products and notifies production immediately of any problems.
• Reviews completed batch records.
• Documents all activities on appropriate forms or in the batch record.
• Maintains a thorough knowledge of appropriate standard operating procedures.
• Samples blends for testing. Collects samples at various stages for process validation studies.
• Understands and oversees the swab sampling procedure for cleaning validation studies.
• Issues batch records and associated forms to production.

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• The requirements listed below are representative of the experience and qualifications required:

• High School diploma or Bachelors degree in life or physical science.
• Industry Experience Required Six(6) to eight (8) years of relevant pharmaceutical or with a Bachelors degree a minimum of four (4) to six (6) years of relevant pharmaceutical experience.
• A minimum of two (2) to four (4) years in a cGMP/Pharmaceutical Quality Assurance environment

Requirements

• The requirements listed below are representative of the knowledge, skills and abilities required
• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Knowledge of basic or commonly used rules, procedures and operations, typically involves step-by-step instructions and requires some previous training or experience.
• Skill to operate and adjust varied equipment for purposes such as performing standardized tests or operations, requiring considerable training and experience.

• Advanced level communication skills with the ability to plan, coordinate and advise on work efforts or to resolve operating problems by influencing or motivating individuals or groups to obtain results.
• This is a highly visible position requiring contact with varied levels of staff.
• Presentation skills a plus with the ability to conduct training of staff on QA SOP?s and GMP.
• Advanced level writing skills with the ability record observations and deviations.

• Intermediate level computer skills with proficiency in Microsoft Office software applications, knowledge and experience with SAP or related MRP system.

• Ability to apply independent judgment regarding what needs to be done based on standard choices required.
• Must be able to recognize the existence of and differences among easily recognizable situations with respect to information or transaction available.

• The working environment demands of this job are physically and environmentally center around characteristics and abilities involved in this work.
• The work environment considers the risks and discomforts in the physical surroundings and the nature of the work assigned to ensure that all safety regulations and techniques required to perform the job are precautions practical to eliminate all risks.
• The work involves moderate risks or discomforts requiring special safety precautions.
• Employees are required to use personal protective equipment such as masks, gowns, coats, boots, goggles, gloves or shields.
• The work requires some physical exertion which may include long periods of standing and walking, recurring bending, reaching or similar activities.