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ProCaps Labs

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QA Team Lead (Manufacturing)

Summary

Oversee a team of QA auditors on a manufacturing floor, enforce cGMP standards, review production records, and escalate quality issues to ensure compliance and product consistency.

POSITION SUMMARY

As the QA Team Lead, you’ll be responsible for overseeing Quality Assurance auditing activities on the production floor to ensure compliance and continuous quality improvement within the production area. This role monitors daily manufacturing operations for adherence to SOPs and cGMP requirements, ensures QA Auditors are effectively performing their responsibilities, and drives timely resolution and escalation of quality issues. The QA Auditor Lead serves as the primary on-shift quality escalation point and ensures consistency, accountability, and effectiveness of QA auditing activities.

Requirements

MINIMUM JOB QUALIFICATIONS

  • 2 years of college with an emphasis in a science related field or minimum 8 years of work experience in a cGMP environment
  • Must possess good computer skills to be proficient in Microsoft office. Be able to quickly learn in-house computer programs
  • Good working knowledge of cGMP’s
  • Strong written and communication skills to include the ability to be effective in working with production operators and supervisors, writing of deviations and non-conformances
  • Must be willing to work overtime or on weekends, as required

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

  • Oversee QA auditors on the production floor to ensure consistent enforcement of cGMP standards and quality requirements
  • Monitor production activities across all stages (dispensing, blending, encapsulation, packaging, labeling) for compliance and quality performance
  • Ensure QA auditors are effectively performing inspections, documentation reviews, process verifications, and real-time enforcement of cGMP practices
  • Review and verify production records, including batch documentation, checklists, and electronic records (e.g., PCLE) for accuracy and completeness
  • Ensure proper inspection, disposition, and handling of in-process materials and finished goods
  • Oversee identification, documentation, and escalation of nonconformances and deviations
  • Review audit findings and ensure appropriate follow-through, including corrective actions and closure of assigned items
  • Ensure QA auditors properly initiate, document, and follow through on deviations, investigations, and assigned corrective actions
  • Identify recurring issues and quality trends and escalate to QA Auditor Supervisor or QA Management with recommended actions
  • Ensure consistency and standardization across QA auditors in inspection practices, decision-making, and documentation
  • Provide guidance, training, and coaching to QA auditors to improve performance and technical competency
  • Coordinate auditor schedules, assignments, coverage, and rotation across production areas
  • Ensure effective communication and shift pass-down reporting between QA auditors and leadership
  • Serve as the primary escalation point for QA auditors on shift and ensure timely resolution or escalation of issues
  • Ensure appropriate decisions are made regarding holding or stopping production, materials, or processes when quality or compliance risks are identified
  • Escalate significant quality risks, repeat deviations, or unresolved issues to QA Auditor Supervisor or QA Management
  • Support audit preparation and participate in internal and external audits
  • Generate daily reports summarizing QA activities, issues, and auditor assignments
  • Recommend process improvements to enhance product quality and operational efficiency
  • Support continuous improvement initiatives within the production and quality systems
  • Perform other duties and responsibilities as assigned

WORK ENVIRONMENT

  • Daily work is on the production floor, standing/walking the majority of the time
  • Working around powders and strong odors; use of a particulate mask will be provided when needed
  • Duties are performed primarily in a smoke-free manufacturing environment
  • We pride ourselves on maintaining a clean and organized environment, fostering a sense of pride and ownership in our space.
  • Our culture is rich in diversity, quality, safety, fun, and respect, creating a vibrant and inclusive atmosphere.
  • We are dedicated to professionalism and growth, continually striving to improve and excel in all we do.

PHYSICAL REQUIREMENTS

  • Frequently required to stand, walk, bend, kneel, crouch, balance, and reach
  • Regularly lift and/or move up to 25 kg / 55 lbs

Benefits

WHAT WE OFFER

  • A competitive start pay of $27/hr depending on experience
  • Excellent Medical, Dental & Vision Insurance at $0 *** when you qualify for the Wellness Program!
  • Paid Time Off, Eight (8) Company Holidays
  • 401k with 4.5% match
  • 100% Company Life Coverage
  • 100% Short Term Disability Coverage
  • Gym Membership Fee Reimbursement
  • Vitamin Allowance + Discounts
  • Company-Funded HS ($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!

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What this application asks

workable

First name, Last name, Email, Phone, Address, Resume, Experience, Education, How would you like us to get in touch?, Proficiency in speaking, reading, and writing in English is required for this position. This requirement is necessary for effective communication, cGMP & Safety protocols, and compliance with company policies.Do you meet this requirement?, Which computer programs or software are you familiar with? (Examples: Microsoft Excel, Word, Outlook, data entry systems, inventory software, timeclock or scheduling tools). Please list any programs you’ve used:, Please include your preferred shift or time of day, and note any limitations we should be aware of:, What are your salary expectations for this role?, What do you know about ProCaps Laboratories, and what excites you most about the opportunity to join our team?, ProCaps Laboratories operates in an environment where certain food allergens may be present including but are not limited to: MILK, EGGS, FISH, CRUSTACEAN SHELLFISH, TREE NUTS, PEANUTS, WHEAT, SOYBEANS, and SESAME. Many of our roles may involve exposure to one or more of these substances. Due to the nature of our manufacturing environment, complete elimination of allergen exposure CANNOT be guaranteed. Are you able to perform the essential functions of this job, with or without reasonable accommodation?, Have you previously worked at ProCaps Laboratories as a Regular Employee, a Consultant, or through a Staffing Agency? If yes, please state dates of employment, position held, and name of Staffing Agency (if applicable):, Do you have any friend(s) and/or relative(s) currently working at ProCaps Laboratories? If yes, please provide the name(s)., Are you referred by a current ProCaps employee? Is YES, please list the employee name(s).

  • This role prefers 8 years of work experience in a cGMP environment. Describe your experience working in a cGMP-regulated manufacturing environment or similar. What was your role? written answer
  • What experience do you have reviewing batch documentation, checklists, or electronic production records (e.g. EBR / MES systems or similar systems) for accuracy and completeness? written answer
  • Tell us about a deviation or investigation you helped drive to closure. What was your role, and what obstacles came up? written answer
  • Describe a process improvement you suggested or implemented in a previous role. What prompted it, and what was the impact? written answer
  • Do you have experience with any of the following? (Select all that apply) choose any
  • Have you supervised, led, or coached other employees in a quality or production role? choose any
  • ProCaps Labs participates in E-Verify, a system used to verify employment eligibility. If hired, will you be able to provide valid/unexpired documents to complete the E-Verify process? yes / no
  • Location & Commute: This is a Full Time; ONSITE role. Please select the option that best describes your current situation. choose any
  • *Please select the option that best describes your current work authorization status in the United States. NOTE: This information is collected only to assess employment eligibility. ProCaps Laboratories does not discriminate on the basis of citizenship, immigration status, or national origin. choose one
  • PLEASE NOTE: ProCaps conducts a thorough background check as part of the hiring process and by submitting this application, you acknowledge and consent to this process if selected for further consideration. A conviction will not automatically disqualify you from employment. We consider the nature of the offense, the time elapsed, and its relevance to the position. Have you ever been convicted of a felony or serious misdemeanor? If yes, please briefly explain (OPTIONAL).
  • PLEASE READ THE FOLLOWING CAREFULLY : I certify that all information provided in this application is true and complete to the best of my knowledge. I understand that any false statement, misrepresentation, or omission may result in disqualification from consideration or, if employed, immediate termination. I understand that submitting this application does not guarantee employment and does not create a contract or promise of future employment with ProCaps Laboratories. I also understand that, if offered employment, my position will be subject to the company’s policies, including background checks, eligibility verification, and compliance with all job-related requirements. Do you acknowledge and agree to this statement? yes / no

See also

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