The Supervisor, Quality Control- Analytical is accountable for driving results in a fast-paced environment, continuously challenging performance in regards to quality standards, systems, and operating procedures. The Supervisor, Quality Control- Analytical leads and manages the Analytical group for the site in Charleston, SC. Responsibilities include the technical oversight of testing and technical writing. The position requires strong leadership behaviors of the Alcami core competencies and non-negotiables, as well as the functional competencies of this profile.
Monitors equipment/instrument operating practices and conditions to minimize equipment downtime, lower maintenance costs, reduce time to run projects, and repeat work.
Monitors the quality of the group and optimizes the efficiency of the work environment.
Provides troubleshooting support as needed.
Oversees execution and provides technical support concerning analytical testing including routine analysis, method transfer, method verification, and method validation focused on in-process testing and cleaning verification/validation of parenteral drug products.
Ensures adherence to department, site, and corporate SOPs and other regulatory requirements.
Conducts investigations individually and in conjunction with clients.
Effectively communicates with clients and internal groups.
Participates in Quality audits as requested.
Responsible for the selection, training, and development, coaching/mentoring, engagement, retention, and performance management of a high performing team to meet the current and evolving needs of the site.
Education and Experience
Bachelor’s degree (Chemistry, or related field of scientific study) required.
5+ years of related pharmaceutical laboratory experience in a cGMP environment required.
2+ years of supervisory experience preferred.
Prior CMO or CDMO experience preferred.
Prior experience in method development/validation and/or transfer/verification, protocols, and troubleshooting required.
Consistently demonstrates honesty and integrity through personal example.
Follows all safety policies and leads by example a safety-first culture.
Produces high quality work product with a focus on first time right.
Complies with the company code of conduct and policies and regulatory standards.
Alcami Core Leadership Competencies
Thinks strategically. Quickly identifies and acts on opportunities. Considers the downstream impact. Seeks to understand the why. Focuses on work that matters.
Develops organization and others. Takes ownership to develop self and others. Seeks out new opportunities and experiences for continuous learning.
Acts decisively. Makes and acts on decisions quickly. Makes decisions with the customer and their patients in mind. Meets commitments with a sense of urgency. Seeks ways to be more efficient.
Drives performance. Holds self and others accountable. Delivers results first time right. Never settles for the status quo. Willing to have tough conversations. Asks for feedback and takes action to improve.
Passion for customers. Listens to understand. Asks the right questions. Gets to the heart of the matter and uses that insight to provide value.
Works collaboratively. Seeks out the experience of others with the aim for better results. Open-minded regardless of where ideas originate. Flexible and easy to work with.
Expert knowledge of cGMP.
Knowledge of method development/validation and/or transfer/verification and protocols.
Knowledge of pharmaceutical analytical testing, and quality principles in a cGMP environment.
Knowledge of raw material, in-process and finished product testing, e.g. ID, appearance, cleaning methods, HPLC, TOC, conductivity, and osmolality (or some combination).
Superior documentation skills and thorough understanding of client management.
Excellent leadership, communication, and presentation skills.
Excellent skills in strategic planning, problem-solving, root-cause analysis, and critical thinking are required.
Directly manages a team, typically up to 8 direct reports.
Participates in the hiring process of other employees.
Makes hiring decisions of other employees.
Schedules and review the work of other employees.
Ensures relevant curriculum assignment and timely completion of training of employees to meet regulatory requirements.
Coaches, mentors and develops other employees.
Prepares and delivers performance evaluations of other employees.
Makes recommendation of disciplinary actions of other employees.
Up to 5% domestic travel
Diversity and Inclusion:
Alcami values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.