Come join Millstone Medical and become part of a high growth company where you will have the opportunity to learn and grow in an employee-centric culture and see the importance of your work!
Millstone Medical Outsourcing, a fast growing, fast paced medical service provider for the top Orthopedic companies in the industry is recruiting at its Connecticut division. Millstone Testing has over 30 years of expertise in medical device and pharmaceutical laboratory testing, environmental testing, and related regulatory support services. Millstone Testing is an ISO 13485:2016 certified contract manufacturing organization operating out of an FDA-registered facility with a rigorous approach to quality that upholds Millstone’s commitment to operating under the highest quality standards.
Millstone also engages in other activities, such as mechanical inspection and assembly, which are designed to meet the outsourcing requirements of medical device manufacturers seeking to reduce costs while maintaining high levels of quality, accuracy, and timeliness. We are FDA and ISO registered and employ a detailed internal quality system to ensure ISO compliance.
What's in it for you?
A company committed to quality, growth, career pathing.
At Millstone, we want you to be your best at work and at home. In addition to competitive compensation, we have designed our Total Rewards Benefits Program to support the physical and emotional well-being of our employees and their families.
Total Rewards Benefits Program:
- Medical - Starting on the 1st day of employment
- Dental - Starting on the 1st day of employment
- Vision - Starting on the 1st day of employment
- Supplemental Benefits - Life, Disability, Critical Illness
- Paid Time Off
- Tuition Reimbursement
- Career Pathing
- 401(k) with match
Job description
The Senior Manager has overall responsibility for leading and managing the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The Senior Manager is the single point of study control. The Senior Manager ensures compliance with regulatory requirements, overseeing the microbiology laboratory operations, and maintaining high-quality standards.
Responsibilities:
- Lead and manage a team of QC microbiology laboratory professionals for a contract testing laboratory, ensuring a high level of technical expertise and adherence to quality standard. Areas include sample management, testing schedules, identification and isolation of detected microbes, equipment maintenance and calibration, inventory control and supply orders.
- Provide guidance and mentorship to staff, fostering a culture of continuous improvement and excellence.
- Act as the primary point of contact and subject matter expert (SME) for customers for all testing services on behalf of the laboratory.
- Management and performance of routine QC testing such as bioburden, endotoxin, B&F testing, growth promotion, Gram stain, microbial ID analysis, preservative efficacy testing and raw materials testing.
- Management/planning of water sampling and associated water testing (basic chemical analysis to include USP test for heavy metals, nitrates, pH, conductivity, etc.).
- Management/planning of environmental monitoring sampling to coincide with testing and manufacturing activities.
- Implement correct actions in response to environmental monitoring excursions.
- Establishing and maintaining procedures for QC testing, including writing/reviewing SOPs, protocols, and reports as necessary as per company’s ISO 13485 QMS.
- Review and complete documentation in accordance with current Good Manufacturing Practices (cGMP).
- Ensure all analytical and microbiological methods are appropriately qualified/validated.
- Ensure the QC group meets set KPIs and develops a program of continuous improvement.
- Play a leading role in regulatory inspections and the preparation for regulatory inspections.
- Ensure reports are compliant with current procedures and that the final reports accurately reflect the data, results, and conclusions of the testing.
- Act as a final signature for assigned studies and ensure sample and data traceability are maintained throughout testing.
- Ensure accuracy of raw data, calculations and statistics accurately reflect the raw data.
Regulatory Compliance
- Knowledge of applicable regulatory requirements (GMP, GLP, ISO, etc.) including technical company policies and procedures.
- Ensure that test procedures are approved, communicated to, and followed by analysts and all data are accurately and concurrently recorded.
- Ensure unforeseen circumstances or any deviations from test methods or other events are recorded and that corrective action is taken.
- Meet or exceed sponsor expectations and communicate regularly with sponsors as needed to relay testing updates.
- Collaborate with cross-functional teams, including Quality Assurance and the Sales department on testing quotes and maintain a general understanding of company pricing and credit policies to support overall organizational goals.
- Coordinate workflow to ensure sponsor expectations are met.
- Keep current with technical and scientific information.
- Ensure analysts are properly trained and that they understand testing performed.
Technical
- Extensive experience in a microbiology laboratory, with a focus on pharmaceutical, biotechnology or medical device products.
- Knowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testing.
- Previous experience in a leadership or managerial role within a QC laboratory.
- Good documentation practice (GDP).
- Effective critical thinking, problem-solving, and decision-making skills.
- Ability to learn and comprehend difficult tasks.
- Ability to troubleshoot problems.
- Attention to detail.
- Effective computer skills: Microsoft Office and laboratory systems.
Professional
- Effective communication skills: verbal, written, and active listening.
- Ability to organize and manage workload.
- Ability to meet deadlines.
Work Environment:
This job operates in a professional laboratory environment. This role routinely uses standard office equipment and lab equipment including but not limited to computers keyboards, computer mouse, telephones, photocopiers, file cabinets, microscopes, micropipettes, pipette aids, various hand tools, and analytical equipment.
Travel
Occasional local travel during the business day and occasional out of the area or overnight travel may be expected.
Physical requirements:
- Requirements to stand and traverse to various office and lab locations and sit at a computer workstation will vary.
- Bending, stooping, and crouching.
- Occasional push and pull tasks with one or both hands.
- Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.
Education and experience requirements:
- B.S. degree in Biology or equivalent
- 5-10 years ISO 17025/13485 Microbiology laboratory experience in a technical management role.
ADDITIONAL INFORMATION:
Millstone provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status, or any other status protected by applicable federal, state, or local law.
All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.
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Job Type: Full-time
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee assistance program
- Health insurance
- Life insurance
- Paid time off
- Referral program
- Tuition reimbursement
- Vision insurance
Schedule:
- 8 hour shift
- Monday to Friday
Application Question(s):
- How many years experience do you have in a microbiology laboratory, with a focus on pharmaceutical, biotechnology or medical device products?
Experience:
- ISO 13485 environment: 1 year (Required)
- QC laboratory management: 1 year (Required)
Ability to Relocate:
- Bloomfield, CT 06002: Relocate before starting work (Required)
Work Location: In person
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