Quality Assurance Specialist

Job Title: Quality Assurance Specialist

Reports To: Quality Assurance Director

FLSA Status: Exempt

Department: QC/QA

WHO WE ARE: Located in Farmville, North Carolina, at CMP Pharma, we address the critical needs of older and younger patient populations through the development and manufacturing of a portfolio of high value semi-solid and liquid products. Our products include leading high-quality branded and generic prescription products, as well as a variety of non-prescription products, which we distribute to hospitals, long-term care facilities, and retail channels.

SUMMARY: This position monitors and provides assurance that quality systems are being performed in compliance with standard operating procedures and FDA regulations. The ideal candidate will be highly motivated, attentive, and can efficiently work independently or as an effective team member.

QUALIFICATIONS: To perform this job successfully, an individual must be able to perform each essential function of the job satisfactorily. The duties and responsibilities listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

DUTIES AND RESPONSIBILITIES:

• Oversight, including revision, review, and approval of company Standard Operating Procedures (SOPs).
• Implementation and oversight of CMP Pharma’s training program.
• Document control of Current Good Manufacturing Practice (CGMP) documents, including Sops, batch records, and validation and qualification documents.
• Final review and approval of:
  1. Finished Product Batch Records.
  2. Packaging supplies, raw materials, and other components used in the manufacturing and packaging of finished products.
  3. Validation and qualification protocol and reports.
  4. Deviations.
  5. Change controls.
  6. Out of specification and out of trend investigations.
  7. Stability protocols and reports.
• Compilation of the Annual Product Reviews for all commercial products.
• Documentation and investigation of customer complaints.
• Audits of vendors of material / service suppliers.
• Schedule and perform internal audits.
• Tracking of deviations, change controls, and Corrective and Preventive Actions (CAPAs), including CAPA effectiveness checks.
• Participate in and support site regulatory inspections.
• May represent QA on cross-functional project teams.

REQUIRED QUALIFICATIONS EDUCATION AND EXPERIENCE

• Education:
  1. Bachelor’s Degree in a science related field, preferred
• Desired Experience:
  1. At least 8 years of experience working within a pharmaceutical organization
  2. At least 4 years of experience working in a quality assurance role
  3. Experience with implementation and management of GMP quality systems
  4. Knowledge of CGMPs, 21 CFR Parts 210 & 211, and FDA Regulations
  5. Good oral and written communication skills
  6. Performed external GMP audits
  7. Knowledge of ERP software, specifically eQMS & QAD.

PHYSICAL REQUIREMENTS (if needed):

• This role may require sitting or standing for periods of time.
• Must be able to lift at least 20 lbs. unassisted.

WORK ENVIRONMENT: The usual work environment is a typical office and/or manufacturing environment. There may be limited exposure to different chemicals. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description is to be used as a guide for accomplishing company objectives. The description incorporates the most typical duties performed and covers only the primary functions and responsibilities of the position. It is recognized that other duties not specifically mentioned may also be performed. The inclusion of those duties would not alter the overall evaluation of this position.