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Status: Full Time
Reports to: Director of Quality
SCOPE OF POSITION
The Quality Control (QC) Manager is responsible for overseeing the Microbiology and Chemistry Laboratories. This position is responsible for oversight of cGMP operations to ensure that products are tested to comply with the requirements of regulatory filings and eliminate risk due to inadequate safety, quality or efficacy. Provide direction to members of the Quality Control Laboratories performing analytical testing of raw materials, in-process products, final products pre-release and stability testing for all current products based upon sound scientific practice and general laboratory and company policies.
DUTIES AND RESPONSIBILITIES:
- Coordinate operations within lab to ensure materials and products are tested, reviewed and approved within the accepted time frames.
- Interprets data, identifies adverse trends, and provides strategic resolution to technical issues with group. Ensures scientific and compliance-based suitability of analytical methods used for testing materials and products through method transfers and method validations.
- Review, author, and edit documents, including deviations, change control requests, SOPs, test methods, analytical investigations, and laboratory test plans and related technical reports.
- Lead microbiology and chemistry validations including but not limited to media fills, cleaning validations, and review of test results for final release of product.
- Provide effective planning for QC Labs to include required resources, and the maintenance & communication of cycle times.
- Lead and manage projects which include microbiology and chemistry department support.
- Ensures investigations related to OOS, unexpected results, or invalids are performed appropriately and within expected timeframes. Ensure investigations are appropriately thorough to identify root causes or potential root causes and prevent recurrence.
- Supporting QA/QC during FDA audits, and enhancing current laboratory methods and techniques.
- Experience in leading analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines
- Other duties as assigned.
- Directly oversees the Microbiology and Chemistry team.
- Carries out managerial responsibilities in accordance with the organization’s policies and applicable state and federal laws.
- Coach, mentor, lead and manage departmental employees. Ensure that training and other personal development programs are in place for succession planning and the development of subordinates. Ensure that performance opportunities are proactively managed through the Performance Management system.
- Responsibilities may also include interviewing, hiring, training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.
REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES:
- Knowledge and experience of FDA regulations related to the manufacture of drugs and devices.
- Strong verbal communication, proficient in technical writing, and excellent interpersonal skills are required.
- Ability to lead multiple testing sub-groups (Microbiology/Chemistry) to provide testing efficiencies while in full compliance with regulatory requirements.
- Ability to lead analytical investigations for Out of Specification or Out of Trend Results in accordance with regulatory guidelines
- Demonstrate knowledge and experience in sterile (aseptic process) and non-sterile pharmaceutical cGMP manufacturing.
- Demonstrate knowledge and experience in analytical method development and validations involving HPLCs, UV Spectrophotometry, etc.
- Demonstrate knowledge and experience working with various equipment HPLC equipment, UV
- Knowledge and experience of including but not limited to USP, NF, and EP standards and monographs
- Exhibit flexibility, open-mindedness, and adaptability to changing environments.
- Complies and adheres to existing and new regulations and complies with all company policies and procedures.
- Comply with all company safety policies and procedures to ensure a safe and healthy environment.
- S. majoring in Microbiology/Biochemistry/Biology or related science.
- Aseptic (class 100, ISO 5) environmental monitoring and sterility testing experience.
- Experience in analytical method development and validations involving HPLCs, UV Spectrophotometry, etc.
- 6+ years of experience in a microbiology/chemistry laboratory of a pharmaceutical manufacturing environment.
- Leadership – Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
- Problem Solving – Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.
- Teamwork – Balances team and individual responsibilities; Exhibits objectivity and openness to others’ views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone’s efforts to succeed.
- Analytical – Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures.
- Technical Skills – Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
PHYSICAL DEMAND & WORK ENVIRONMENT:
- May occasionally lift and /or move more than 15 lbs.
- While performing the duties of this job, the noise level in the work environment is usually moderate.
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