About the role

The QA Compliance Supervisor oversees the quality assurance team, managing regulatory compliance, deviations, CAPA processes, and customer complaint investigations. They are also responsible for staff training, performance coaching, and reporting key performance indicators related to quality nonconformances.

What they look for

Quality assurance Regulatory compliance Staff supervision Performance coaching Microsoft office cGMP CAPA Deviation management Customer complaints Root cause analysis SOP development Risk scoring Internal auditing Supplier qualification Change control KPI monitoring

Requirements

Candidates must hold an associate degree or equivalent experience and possess proficiency in Microsoft Office and cGMP standards. Strong analytical, problem-solving, and communication skills are required, along with the ability to work overtime or weekends as needed.

Benefits

Medical coverage Dental coverage Vision coverage Paid time off Company holidays 401(k) with company match Life insurance Short term disability coverage Gym membership reimbursement Vitamin allowance Health savings account Cash reward Employee referral program Pet insurance

Full description

The Quality Assurance Compliance Supervisor is responsible for supervising and coordinating the activities of the Quality Assurance team engaged in the regulatory compliance related to Quality Assurance of the organization. Additional duties include staff selection, training, performance coaching, and professional development.

MINIMUM JOB QUALIFICATIONS AND REQUIREMENTS• Associates degree or equivalent experience commensurate to the industry

Must possess good computer skills to be proficient in Microsoft office
Be able to learn, use and train on in-house computer programs (PCLE)
Experience in cGMPs in a regulated industry
Experience with CAPA, deviations, and customer complaints preferred
Detail-oriented, with developed analytical skills and strong problem-solving skills
Strong written and verbal communication skills to include the ability to be effective in working with production operators, supervisors and management
Must be able to work overtime or on weekends as needed

OTHER ESSENTIAL JOB DUTIES AND RESPONSIBILITIES• Oversee the QA assessment of customer complaints utilizing risk scoring methodology.

Administer the organization’s deviation process.
Assign tasks and delegate activities related to the internal investigation processes.
Conduct / lead root cause investigations related to nonconformances, deviations, CAPA, SCAR, and customer complaints
Review and update SOPs related to job responsibilities
Ensure deviation, CAPA, and customer complaint assessments and investigations are addressed and completed in a timely manner
Assist in the material review board meeting and weekly QA meetings to develop, train and communicate the status of ongoing investigations
Trend, monitor, and report KPIs associated with nonconformances, deviations, CAPA, SCAR, and customer complaints.
Assist with cGMP internal audits, write, and respond to internal audit reports
Train QA specialists supporting this role.
Assist with supplier qualification and approved supplier process
Direct supervision of inspection, investigation, and review processes and QA Specialists

· Review Change Control documentation for specification consistency

· Assist in the label review process

Perform other duties and responsibilities, as assigned

WORK ENVIRONMENT

Duties are performed primarily in a smoke-free office and production environment

PHYSICAL REQUIREMENTS

Frequent sitting, standing, walking, and climbing
Able to lift up to 25 lbs.

ProCaps provides :

A competitive salary!
Top-Tier Medical, Dental & Vision Coverage - $0 when you qualify for the Wellness Program!
Paid Time Off, Eight (8) Company Holidays
401(k) with Company Match – up to 4.5%
100% Company Life Coverage
100% Short Term Disability Coverage
Gym Membership Reimbursement
Vitamin Allowance + Discounts
Company-Funded Health Savings Account ($1,600/year)
Cash Reward Employee Referral Program
Pet Insurance

*** Fantastic work environment that focuses on Safety, Quality, Community, and amazing people. We hire top talent and celebrate the ingenuity and tenacity of our team members and leaders!