From ProCaps Labs's posting. “We” and “our” refer to the employer.
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.
Requirements
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.
Benefits
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!
About this listing
LAYIQ is an independent job-discovery service. This listing does not imply a partnership with or endorsement by the employer. Review the original posting for current details and availability.
