Qc Supervisor

EQUAL OPPORTUNITY EMPLOYER

Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

The QC Supervisor provides direct supervision for the Quality Control Department in accordance with organizational policies and applicable laws and guidance. Responsibilities include developing employees; planning, assigning, and directing work; meeting goals and performance standards; and driving continuous improvement. The incumbent is responsible for creating an environment that encourages compliant efficiency, developing and coaching technical staff to improve skills, and ensuring high quality technical work. In this role, the QC Supervisor is responsible for the coordination, execution, and transfer of new processes into the QC Department as well as ongoing process performance.

Performs a variety of chemical, biological, or microbiological analyses on products, raw materials, in-process materials, or stability samples in support of the company's quality control program. Provides technical specialties and coordinates activities of personnel engaged in performing chemical and physical tests required for quality control of processes and products by performing the following duties.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Provides supervision to direct reports. Conducts performance reviews on reporting staff
• Responsible for safe work practices of staff
• Maintains training for reporting staff members
• Performs laboratory investigations
• Performs data review of laboratory data
• Establishes and maintains strong, transparent, and effective day-to-day working relationships between Manufacturing, R&D, internal support, regulatory groups, and CPC customers related to assigned duties
• Actively collaborates with other manufacturing centers of excellence and promotes cross-functionality where needed and/or where practical. Communicates with peers and management to ensure that QC priorities are adequately defined and coordinated
• Executes the efficient transition of processes from the clients or development into QC. May represent QC as part of the early process technical team, ensuring that method design and technology are compatible with roll-out to QC. Executes roll-out of QC processes
• Leads programs to plan, execute, review, and improve QC activities. Participates in the resolution of operational, process, equipment, and maintenance problems to prevent operational upsets
• Directly or indirectly ensures that all Process and QC Documentation Systems are maintained and executed to current expectations. Ensures that documentation is issued in a timely fashion and is completed within acceptable timelines. This includes final controls, change control, training information, safety procedures (e.g., shutdowns) and specialized operating procedures
• Ensures that QC processes are executed to the planned timing, to meet quality deliverables. Advises management when revision of QC manpower, schedules, and priorities are required
• Provides input to annual operating budget and communicates issues with adherence within budget targets
• Implements and maintains adherence to all company policies concerning Environmental, Health, Safety, Quality, and Human Resources
• Reviews, approves, and issues labels for final control APIs
• Develop and maintain department and site goals. Maintain and monitor department KPIs

LEADERSHIP & BUDGET RESPONSIBILITIES

Coordinates operational staff and facilitates activities of technical (or other support) staff in the commercial QC areas. Acts as a single point of contact for implementation of a new process in the QC areas. Acts as backup when manager is out of the office. Provides ownership of QC processing technologies and specialized unit operations. Supplies input into annual spending and CAPEX forecasts and participates in strategic capability planning

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.

QUALIFICATIONS

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION and/or EXPERIENCE

Bachelor’s degree from a 4-year college; or 10 years related experience; or equivalent combination of education and experience.

LANGUAGE SKILLS

Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence, and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis, etc.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.

CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDS

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance vision, depth perception, and ability to adjust focus.

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is occasionally exposed to moving mechanical parts, fumes or airborne particles, low levels of toxic or caustic chemicals, outside weather conditions, and vibration. The noise level in the work environment is usually moderate.

CORE COMPETENCIES

These are the specific areas of knowledge, skill and ability that are important for successful job performance. They must be job related and consistent with business necessity.

• Results oriented approach to process performance
• Strong leadership, delegation, verbal, and written communication skills
• Ability to build relationships and influence and motivate others
• Ability to achieve results through the positive direction of others
• Coaching and mentoring skills
• Technical expertise in the practices and technologies used in QC, and the ability to use these skills in active projects
• Advanced knowledge of chemical processing, lab equipment, and infrastructure
• Analytical problem-solving skills, including the execution of LEAN operational excellence systems, where applicable
• Familiarity with investigation and incident response tools (e.g., cause mapping), CAPA management, and team-based problem resolution
• Working knowledge of regulatory compliance issues in pharmaceutical manufacturing
• Facilitation skills
• Planning, implementation, and follow-up skills
• Responsible for training of new technicians and analysts
• Confers with scientists or engineers to conduct analyses, interpret test results, or develop nonstandard tests
• Interprets and evaluates the analyses of stability and finished good samples in terms of accuracy and precision
• Generate and review required certificates of analysis and labels for outbound shipments before releasing to shipping personnel, to ensure all parameters are within specification ranges
• Performs qualitative tests or quantitative assays on samples using techniques that vary from use of standard analytical equipment to highly modern and automated instrumentation
• Prepares test solutions, compounds, and reagents for use by laboratory personnel in conducting tests
• Supports development of new methods qualification and revise current methods in support of current processes and technology transfer project
• Responsible for properly managing the generation and accumulation of hazardous and non-hazardous waste

SALARY

Actual pay will be based on your skills and experience.

BENEFITS

• 401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
• Accident Plan
• Critical Illness Insurance
• Dental Insurance
• Disability Insurance
• Employee Assistance Program
• Flexible Spending Account
• Health Insurance PPO/HSA
• Hospital Indemnity Plan
• ID Theft Protection
• Life Insurance
• Paid Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance