This job has closed.

Corden Pharma - A Full-Service CDMO · 2 weeks ago

QC Supervisor

Boulder, CO

Full-time

Onsite

Senior Level, Lead/Staff

$100K/yr - $110K/yr

10+ years exp

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients and drug products. The QC Supervisor is responsible for supervising the Quality Control Department, ensuring compliance and high-quality technical work, and coordinating processes within the department.

BiotechnologyManufacturingPharmaceutical

H1B Sponsor Likely

Responsibilities

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

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

Every individual is personally responsible for the safety and environmental aspects of his or her activities in the workplace

Qualification

Technical expertise in QCAdvanced knowledge of chemical processingRegulatory compliance knowledgeAnalytical problem-solvingCoachingMentoringPlanningImplementationLeadership skillsVerbal communication skillsWritten communication skillsFacilitation skills

Required

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

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

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

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

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

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 Parental Leave

Tuition Reimbursement

Wellness Program

Vacation – Three Weeks 1st Year

Vision Insurance

Company

Corden Pharma - A Full-Service CDMO

CordenPharma is your full-service partner in the Contract Development & Manufacturing (CDMO) of APIs, Lipid Excipients, Drug Products and Packaging.

Founded in 2006

Basel, Basel-Stadt, CHE

1001-5000 employees

http://cordenpharma.com

H1B Sponsorship

Corden Pharma - A Full-Service CDMO has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2020 (2)