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.
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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.
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EDUCATION/EXPERIENCE

• Bachelors' degree in chemistry, biology or other related field.
• Minimum three years' laboratory experience in the pharmaceutical industry.Work environment
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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.

Current Openings for Quality Control Compliance Specialist Jobs at Zydus Pharmaceuticals