Quality Assurance Associate

About the role

Reporting to the QA Supervisor, the QA Associate will work within an established culture of Quality Assurance and continuous improvement in all GMP areas. The QA Associate will be directly involved in all areas of quality assurance, including change control, facility compliance, product and material release, review of technical documents, deviation resolution, and ensuring GMP standards are met. The role includes coaching/training operators and supervisors on proper documentation practices and on cGMP requirements to ensure compliance during manufacturing.

Shift Availability

Day Shift: Monday – Friday, 8:00 AM – 4:30 PM

Responsibilities

• Assess potential impact of incidents and processing deviations on the quality and suitability of the product for sale, including conducting batch record review and determining batch status (e.g., release, reject, or product hold for further clarification or investigation).
• Conduct incoming inspection of printed roll-stock, labels, inserts, and cartons using statistical sampling plans to determine acceptability of printed labeling; interact with label vendors if problems exist.
• Investigate, individually and as a team member, product complaints, deviations, and OOS results to determine product impact, root cause, and corrective/preventative actions.
• Perform internal quality audits compliant with corporate policies, practices, and procedures.
• Promote and advocate quality achievement and performance improvement across the organization.
• Ensure ongoing compliance with local, national, and international standards and legislation.
• Participate in HPRA, FDA, and customer audits/inspections and ensure corrective actions are completed as required.
• Perform initial inspection of packaging lines to ensure compliance with company Standard Operating Procedures (SOP).
• Assist with resolution of compliance issues related to manufacturing lines to ensure compliance with company SOP.
• Write, review, and revise Standard Operating Procedures (SOP) and related forms for specific job-related activities.
• Support the Continuous Improvement program throughout the company.
• Review batch documentation for cGMP compliance and work with production personnel to resolve discrepancies.
• Perform QA release of finished product for acceptable materials, including counting and tagging outgoing pallets of finished products; establish files for all batch documentation.
• Prepare raw materials and finished product samples for submission to the Quality Control laboratory; monitor completion of testing and receipt of necessary documentation to facilitate Finished Product and Raw Material releases; review completed analysis for conformance to specifications.
• Keep management informed of discrepancies, deviations, investigations, and unusual trends as they occur; assist in identifying root cause and countermeasures to prevent recurrence.

Requirements

• Minimum 1+ years of direct work experience with pharmaceutical or food manufacturing Quality Assurance systems, regulations, guidelines, and associated standards.
• Training and knowledge of cGMP regulations.
• Extremely detail-oriented and analytical thinker with strong problem-solving ability.
• Able to develop, review, and maintain metrics and quality audits.
• Able to interface directly with cross-functional teams.
• Proficiency in use of computer applications and programs such as Microsoft Office, Excel, and PowerPoint.
• High integrity, excellent attention to detail, analytical thinker, ability to organize and prioritize, and work in team environment; take initiative.
• Highly motivated and self-directed; capable of multi-tasking and able to work with minimal supervision.
• Strong work ethic and positive team attitude.
• Bachelor’s degree in a related Science or equivalent experience.

Competencies Required for the Role

• Fostering Collaboration/Teamwork: ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance. Respects others.
• Effective Communication: ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts. Exhibit willingness to listen and show respect for oneself and others in interactions with others, express oneself clearly in verbal and business writing.
• Execution/Accountability: a willingness to accept responsibility or to account for one’s actions. Accountability is when an individual or a department experiences consequences for their performance or actions.
• Analytical Thinking/Problem Solving: ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this.
• Thoroughness/Detail Oriented: ensuring that one’s own and others’ work and information are complete and accurate, carefully preparing for meetings and presentations, following up with others to ensure that agreements and commitments have been fulfilled.

Benefits

• Health Insurance (medical, dental, vision)
• 401(k) plan for retirement savings
• Paid time off (vacation, sick leave, holidays)
• Life insurance
• Employee assistance program