Job Title: Quality Assurance Manager
Desired Character Qualities: Detailed oriented, Attentiveness, Dependability, Diligent, Confident, Calm, Resourceful, Thorough, Truthfulness, Loyalty, Trustworthy
Job Summary: Is responsible for managing and performing daily QA and QC responsibilities to ensure products are constructed, performed, maintained and documented in accordance to the industry, FDA, and OSDH standards and specifications. This position reports to the CEO.
Essential Job Functions:
- Direct oversight of QA/QC Department; supervise and delegate to others to maintain the timely completion of tasks.
- Ensure that quality issues concerning production are effectively addressed.
- Assess the quality/compliance impact of a change request on product quality and manufacturing systems for approval.
- Ensure that standard operating procedures are followed, remain consistent with current practices, and are reviewed and updated as necessary.
- Responsible for the review, approval, and management of the training program for all SOPs, Working Instructions, associated cGxP Form(s), and cGxP Template(s) are performed.
- Work with clients and sub-contractors to define critical-to-quality elements and responsibilities for completion of an approved Quality Agreement.
- Handle both planned and unplanned deviations, assessing the impact on product identity, strength, quality, purity, as well as determining the need for investigation.
- Assist in handling FDA inspections and Client audits for cGMP compliance; answer questions and respond to observations; completion of a Summary Report.
- Review all records and deciding on measures to be taken in material complaint handling.
- Review all complaints and product defects to determine the need for a product recall; execute and coordinate product recalls, and decide what measures are to be taken.
- Quality Assurance Document Managing – responsible for assuring that all documents are properly stored and distributed.
- Determine, negotiate and agree on in-house quality procedures, standards, and specifications.
- Establish quality requirements of raw materials.
- Provide supplier corrective action, when applicable.
- Oversee and test all raw, intermediate and finished goods in alignment with specifications for conformance.
- Complete Final/Finished product releases.
- Set standards for quality as well as health and safety.
- Look for ways and means to reduce waste and increase efficiency.
- Make suggestions for changes and improvements, demonstrating how to implement them when approved.
- Using relevant quality tools, ensure that managers and other staff understand how to improve efficiency.
- Continually improve the systems and processes in the company for better compliance.
- Comprehensive knowledge and understanding of applicable FDA regulations and cGMP.
- Ability to communicate effectively with both internal and external personnel.
- Strong experience working with electronic documentation management systems (EDMS), such as Instant GMP.
- Strong computer skills, including ability to work effectively with Microsoft Office.
- Possess innovative, resourceful, and proactive outlook, committed to ensuring continuous improvement of capacity and delivering quality service.
- Ability to expect challenges and proffer effective solutions to them.
- Experience assisting regulatory inspections and/or audits.
- Strong problem-solving skills.
- Skilled in numerical and statistical analysis.
- Proven demonstration of interpersonal proficiency.
- Display of effective team work ability.
- Managing Performance: – the ability to take responsibility for performance by setting clear goals and expectations, tracking progress, ensuring feedback and addressing performance problems and issues promptly.
- Managing Change The ability to take responsibility for one’s own or one’s employees’ performance, by setting clear goals and expectations, tracking progress against the goals, ensuring feedback, and addressing performance problems and issues promptly.
- Attention to Communication: The ability to ensure that information is passed on to others who should be kept informed.
- Oral Communication: The ability to express oneself clearly in conversations and interactions with others.
- Written Communication: The ability to express oneself clearly in business writing.
- Interpersonal Awareness: The ability to notice, interpret, and anticipate others’ concerns and feelings, and to communicate this awareness empathetically to others.
- Building Collaborative Relationships: The ability to develop, maintain, and strengthen partnerships with others inside or outside the organization who can provide information, assistance, and support.
- Diagnostic Information Gathering: The ability to identify the information needed to clarify a situation, seek that information from appropriate sources, and use skillful questioning to draw out the information, when others are reluctant to disclose it
- Analytical Thinking: The ability to tackle a problem by using a logical, systematic, sequential approach.
- Results Orientation: The ability to focus on the desired result of one’s own or one’s unit’s work, setting challenging goals, focusing effort on the goals, and meeting or exceeding them.
- Thoroughness: 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.
Supervisory Responsibilities: Yes
- Possession of Bachelor’s or Master’s degree in a scientific discipline or equivalent; two years or more working experience in a relevant, cGMP/FDA regulated industry is desirable.
- Lab/production environment – PPE required in most areas.
Please send resumes to Adam Payne at firstname.lastname@example.org.