Nesher Pharmaceuticals (USA) LLC

Data Review Quality Control Compliance Specialist Jobs at Nesher Pharmaceuticals (USA) LLC

Data Review Quality Control Compliance Specialist Jobs at Nesher Pharmaceuticals (USA) LLC

Sample Data Review Quality Control Compliance Specialist Job Description

Data Review - Quality Control Compliance Specialist

summary

Monitor the compendia (i.e. USP and Ph. Eur.) and ensure method and respective specifications are updated concurrently with compendia revisions. Generate and revise methods, specifications, and SOPs through Change Control to reflect current procedures. Support daily lab operations as necessary including routine commercial stability operations.

 essential Duties and Responsibilities

  • Monitor compendia (i.e. USP and Ph. Eur.) and ensure QC methods and respective specifications are updated concurrently with compendia revisions.
  • Review vendor tech packages as appropriate and subsequently update methods/specifications through change control.
  • Create and update Quality Control test methods and specifications through change control.
  • Create and update Quality control SOPs through change control.
  • Update Quality Control metrics monthly.
  • Maintain day-to-day commercial stability operations; i.e. initiate studies, sample pulls, stability report updates, etc.
  • Assist in trending USP Purified Water, Environmental Monitoring, and Compressed Air data.
  • Assist in trending commercial product against control limits.
  • Assist in creation of control limit, water trend, EM trend and CA trend reports.
  • Assists in entering Training data in to the LMS.
  • Lead continuous improvement projects.
  • Participate in Regulatory Inspection activities as assigned by Quality Control Management.
  • Prepare QC documentation needed for Regulatory Inspections.
  • Provide historical data when required for review, trending or annual product reviews.
  • Assist in data review within the Quality Control department.
  • Assist in sample testing within the Quality Control department.
  • Create and update manually generated Certificates of Analyses.
  • Perform other related duties as assigned to meet departmental and Company objectives.

KNOWLEDGE/SKILLS/ABILITIES

  • Results-oriented, methodical approach to problem solving. Ability to act as advocate for consensus on complex issues.
  • Proficient in the use and understanding of compendia (i.e. USP and Ph. Eur.)
  • Demonstrated proven leadership skills as recognized by supervision, including motivation, coordination and multitasking activities.
  • Proven initiative to take on new assignments and demonstrate minimum documentation errors.
  • Proficient in Microsoft Office suite.
  • Proficient in MiniTab statistical software.
  • Detail oriented with strong oral and written communication skills.
  • Ability to complete assigned tasks with minimal supervision.
  • Ability to work with a diverse group of people in a fast paced, rapidly changing environment.

EDUCATION/EXPERIENCE

  • BS Chemistry Degree.
  • Minimum three years' laboratory experience in the pharmaceutical industry.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  1. Stand, walk, sit, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk, and hear.
  1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  1. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  1. Individual is in a proximity to moving mechanical parts and exposure to chemicals.
  2. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

 

SUMMARY

Provide formulation/process development/scale-up expertise for the development of immediate release and extended-release oral solid dosage forms. Perform scale-up for oral solid dosage forms. Provide support to product lifecycle development and ongoing efforts for process improvements. Write experimental protocols, and assist in equipment set-up and the manufacture of pilot /manufacturing scale batches. Execute experimental protocols, assist in sample collection and submission for testing, and perform physical tests as required. Write and issue protocol summary reports and assist in Technology Transfer of products from Development to Operations. Provide support to Quality Assurance and Operations with respect to major process/product problems. Initiate and monitor stability studies pertaining to new product development.

 

ESSENTIAL Duties and Responsibilities

  • Support Quality by Design (QbD) efforts for the reintroduction of previously approved and manufactured products and new products.
  • Write experimental protocols and protocol summary reports.
  • Assist in equipment set-up and manufacture of pilot/manufacturing scale batches.
  • Write development Master Batch Records and development Master Packaging Records.
  • Provide input and support to Formulations Group in prototype, scale-up and exhibit batch manufacture.
  • Provide input and assistance to Operations and Quality Assurance Validation in the scale-up, validation and launch for the reintroduction of previously approved and manufactured products, and new products.
  • Provide input and assistance to Quality Assurance and Operations for major process/product problems. Carry out experimental studies to support vendor qualification efforts.
  • Recommend and justify the purchase of new equipment for Research & Development. Assist Engineering in the Installation and Qualification of Research & Development equipment
  • Establish/maintain outside contacts for information exchange regarding manufacturing technologies, theories and developments.
  • Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
  • Perform other related duties as assigned to meet departmental and Company objectives.

 KNOWLEDGE/SKILLS/ABILITIES

  • Thorough knowledge of Pharmaceutical Technology and Pharmacy, Chemistry and/or Chemical Engineering.
  • Demonstrated and applied knowledge of pharmaceutical manufacturing equipment, especially with respect to equipment and processes used to manufacture immediate and extended -release oral solid dosage forms.
  • Broad knowledge of development and manufacturing procedures gained through education and experience.
  • Thorough knowledge of cGMPs and other regulatory requirements governing pharmaceutical manufacturing.
  • Good communication and analysis skills.
  • PC proficiency using Microsoft Office.

 Education/Experience

  • Bachelor's degree in pharmacy, chemistry or chemical engineering.
  • Five years' experience in Formulations, Process Development or Technical Services, with direct experience in formulation and process development of immediate and extended-release oral solid dosage forms. Experience with dry blending, wet granulation, compression and tablet film coating, and powder encapsulation required.

Work environment

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

  1. Stand, walk, sit, climb, balance, stoop or crouch, kneel, reach, push, pull, grasp, feel, talk, and hear.
  1. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
  1. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally and/or up to 50 pounds of force rarely by utilizing a hand truck to lift, carry, push, pull or otherwise move objects.

 The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

  1. Sufficient noise to occasionally cause the individual to shout in order to be heard above the ambient noise level.
  1. Individual is in a proximity to moving mechanical parts, electrical current and exposure to chemicals.
  2. Atmospheric conditions sometimes expose individual to dust, for which protective equipment is available.
  3. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

 We are an equal opportunity employer M/F/D/V.

 

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