Quality Control Lead - 2nd Shift

The Quality Control Lead, Production ensures compliance in company programs to maintain adherence to procedures, processes, and cGMP standards.

The QC Lead, Production provides cGMP oversight, process leadership, and quality-related guidance on the production floor regarding documentation, inspection, and manufacturing / packaging processes.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Perform quality control functions including but not limited to component inspections, in-process inspections and finished product inspections according to established procedures.
• Determine proper in-process test standards and assure compliance to established standards.
• Perform sampling and inspection of bulk drug and excipients.
• Set aside and maintain customer or Sharp Clinical Services reserve samples.
• Provide guidance to QC production team on inspection techniques, good documentation practices (GDP), and resolving any technical questions which may arise on shift.
• Perform physical testing using basic inspection instrumentation.
• Perform daily verification activities (temperature, humidity, weight on balances, etc.).
• Change status of material, GMP areas, equipment and utensils.
• Determine if in-process test results are within established specifications. Responsible for suspending operations and notifying supervisor of any out of specification results.
• Perform pre-production line clearance to the GMP area prior to the initiation of production.
• Perform verification of drug product and components against approved Manufacturing Instructions prior to the initiation of production.
• Perform verification of cleaned GMP areas, equipment and utensils.
• Perform inspections thoroughly and with an exceptional level of detail in regard to quality.
• Excel in operating equipment.
• Identify and implement process changes that enhance efficiency and compliance of routine work.
• Author and revise SOPs and procedures.
• Provide thorough and effective training to QC trainees on cGMP, SOPs, BRs and quality events.
• Provide solutions or insight to other QC personnel regarding routine tasks.
• Ensure testing is in adherence to current procedures and sampling plans.
• Ensure compliance with cGMP and Sharp Clinical Services SOPs during clinical and commercial supply production.
• Ensure employees and visitors comply with applicable Sharp Clinical Services, Inc. SOPs.
• Assist in writing or executing change controls, CAPAs, investigations, technical problems, procedures, complaints and non-conformances which are approved in a timely manner.
• Maintain accurate, detailed records of work performed.
• Provide timely communication of quality or cGMP issues to supervisor.
• Work with internal staff to meet scheduled requirements in a timely manner.
• Remain accountable for maintaining a clean, orderly and safe work environment.
• Adhere to set safety standards.
• Participate actively in routine meetings.
• Achieve expected performance measures.
• Communicate effectively and professionally.
• Demonstrate strong interpersonal skills, is approachable, engaged, presentable, and helps others.
• Perform other duties as assigned.

QUALIFICATIONS

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

• High School Diploma, Bachelors’ Degree or equivalent in related field preferred.
• Preferred 5 years of prior experience in pharmaceutical or biotech manufacturing / packaging (a Quality Control, Quality Assurance, Manufacturing or Compliance role is preferred).
• Ability to work independently, handle multiple tasks simultaneously and negotiate and meet critical timelines.
• Excellent oral and written communication is required to communicate with the team, peers, management and external contacts.
• Ability to interpret and implement cGMPs, FDA & DEA Regulations and CFRs.
• Strong working knowledge of personal computers and Microsoft Office Products, including Word, Project and Excel.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job.

While performing the duties of this job, the employee is frequently required to stand, use hands to finger, handle or feel, reach with hands and arms and talk or hear.

Employee is occasionally required to walk and sit. The employee must occasionally lift and / or move up to 30 pounds.

Specific vision abilities required by this job include close, distance, ability to adjust focus, color and depth perception.

ENVIRONMENTAL CONDITIONS

While performing the duties of the job, the employee is occasionally exposed to fumes or airborne particles and is frequently working near moving mechanical parts.

The employee is required to wear PPE such as a lab coat, safety glasses, and on occasion, an N-95 and PAPR (respirator).

The noise level in the work environment is usually moderate