The Quality Associate will be responsible for the coordination and execution of Quality Assurance (QA) and Quality Control (QC) tasks at the Hamilton, NY production facilities. The Quality Associate will coordinate with Production Management to ensure all required duties are performed according to the Production schedule.

• QC duties include collection of Environmental Monitoring (EM) data in classified production areas at the facilities, analyzing data and reporting EM results, maintaining inventory of approved EM materials, and preparing reports as needed.
• QA duties include performing inspection and release of materials and components to be used in production, staging and issuing printed materials to be used in production, generating, issuing, and reviewing controlled documentation for production batch records, monitoring equipment, charts and gauges to ensure that equipment is operating according to specification, review of equipment cleaning and area clearance documentation prior to Production start-up, and maintaining consistent communication with Quality Management and Production to ensure lines run smoothly and in compliance with expected standards.

Additional essential duties of this role include:

• Assistance with audits, investigations, troubleshooting, and problem resolution; assistance with implementation and follow-up on any corrective action that may result.
• Assistance in training Production personnel on GMP, aseptic techniques, and applicable SOPs.
• Assisting off-site Quality and Compliance functions with preparation and review of necessary reports, investigations, batch record documentation, and standard operating procedures and other standards, technical documents, and risk assessments, as needed.
• Supporting new projects and initiatives by providing input from a quality and compliance perspective.
• Leading cross-functional projects aimed at process improvement, compliance enhancement, or implementation of new systems, equipment, or procedures.
• Providing QA/QC support/back-up at other facilities, as needed.

This role also requires representation as the New York State Board of Pharmacy Supervisor for the facility, which requires maintaining appropriate records for products manufactured at the facility, ensuring proper storage of products at the facility and limited access to prevent loss or damage of products, and ensuring compliance with company procedures and regulatory/GMP standards.
Education: Candidates should have an Bachelors’ Degree in Chemistry or equivalent, and one to two years in a pharmaceutical or other manufacturing environment performing like duties. Knowledge of cGMP’s preferred.
Working hours: 1st shift hours are typically Monday - Thursday, 6:00a.m. to 4:30p.m. Candidates must be flexible for additional work days per week and/or additional hours per day.
Rate is commensurate with experience.

COMPANY DESCRIPTION:

Privately owned and operated since 1846, Hanford Pharmaceuticals is a highly respected contract manufacturer specializing in manufacturing and filling sterile, injectable antibiotics, non-sterile intra-mammary infusions and other pharmaceutical products for veterinary and human use. We offer a competitive salary and benefits package including Roth accounts and 401(k) with an employer match, 12 paid holidays, employee appreciation programs, excellent medical and dental insurance plans, generous vacation benefits, and more! EOE
Job Type: Full-time
Pay: From $24.00 per hour

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Parental leave
• Referral program
• Tuition reimbursement
• Vision insurance

Work Location: In perso

The Quality Associate will be responsible for the coordination and execution of Quality Assurance (QA) and Quality Control (QC) tasks at the Hamilton, NY production facilities. The Quality Associate will coordinate with Production Management to ensure all required duties are performed according to the Production schedule.

• QC duties include collection of Environmental Monitoring (EM) data in classified production areas at the facilities, analyzing data and reporting EM results, maintaining inventory of approved EM materials, and preparing reports as needed.
• QA duties include performing inspection and release of materials and components to be used in production, staging and issuing printed materials to be used in production, generating, issuing, and reviewing controlled documentation for production batch records, monitoring equipment, charts and gauges to ensure that equipment is operating according to specification, review of equipment cleaning and area clearance documentation prior to Production start-up, and maintaining consistent communication with Quality Management and Production to ensure lines run smoothly and in compliance with expected standards

Additional essential duties of this role include:

• Assistance with audits, investigations, troubleshooting, and problem resolution; assistance with implementation and follow-up on any corrective action that may result.
• Assistance in training Production personnel on GMP, aseptic techniques, and applicable SOPs.
• Assisting off-site Quality and Compliance functions with preparation and review of necessary reports, investigations, batch record documentation, and standard operating procedures and other standards, technical documents, and risk assessments, as needed.
• Supporting new projects and initiatives by providing input from a quality and compliance perspective.
• Leading cross-functional projects aimed at process improvement, compliance enhancement, or implementation of new systems, equipment, or procedures.
• Providing QA/QC support/back-up at other facilities, as needed