Bristol Myers Squibb Company

Quality Assurance Manager, (Sterile & Non Sterile) Weekends

Location
Manati, PR, United States
Posted
Aug 26, 2020
Ref
R1528938
Required Education
Bachelors Degree
Position Type
Full time
At Bristol Myers Squibb, we are inspired by a single vision - transforming patients' lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

Shift days and hours:

4 days a week: Friday, Saturday, Sunday and Monday

Friday 8 hours, Saturday 12 hours, Sunday 12 hours, Monday 8 hours

Accountable for providing Quality Assurance guidance to one of the following business units: Parenteral Manufacturing, Oral Solid Dosage and Packaging products to assure these products are manufactured in accordance with cGMP's, regulatory requirements, guidelines and product registrations. This position must comply with all Security guidelines, Environmental Health and Safety regulations, regulatory/compliance requirements, and the current Good Manufacturing Practices required by the job function.

Responsibilities:

1. Ensures quality assurance functions are aligned to support the site business units.
2. Reviews and approves product / processes related documentation such as: Validations, SOP's, etc.
3. Provides quality support to the business unit to optimize compliance and efficiency.
4. Assures the resolution of products and process issues associated to Quality Events.
5. Supports the inspection certification process.
6. Provides guidance to the site Change Control activities to assure they are in compliance with all regulatory requirements.
7. Supports the QC/QA efforts during the transference and validations of parenteral products at the site.
8. Supports the site audit readiness activities related to Parenteral Products manufactured at the site. Ensure that themanufacturing and packaging procedures are properly followed and adequate for their use.

9. Writes, reviews and implements departmental procedures to update them with current practices and Regulatory requirements.
10. Approves the Certificate of Analysis (COAs) for products, according to market requirements.
11. Coordinates priorities to assure timely product releases for different markets.
12. Assures an appropriate lot disposition for all parenteral products.
13. Supports departmental budget preparation activities.
14.Promotes and model the BMS Core Behaviors, facilitating teamwork, providing coaching, feedback etc.
15. Supports all site Initiatives in addition to the product transfer initiatives and any other assignments based on
business needs.
16. Ensures there are effective systems for the maintenance and calibration critical equipment and approves calibration requests.
17. Reviews and approves equipment, utilities and facilities qualification and system life cycle documentation.
18. Provides appropriate information to and obtain the Qualified Person's approval as required by the specific European Union (EU) regulatory authorities.
19. Reviews and approves all process, product and computer systems validation protocols and reports, change control documentation, redressing / reprocessing / rework operations, investigation reports related to manufacturing process and microbiology laboratory, and Annual Product Quality Review (APQR's) elements.
20. Reviews supporting data for compliance with cGMP documentation practices.
21. Verifies compliance with BMS Policies and Guidelines.
22. Participates as quality representative or liaison in site projects
23. Supports Process/Manufacturing decisions during audits with regulatory agencies.
24. Performs pre-operational review form approval in the manufacturing and packaging area.
25. Administers investigations and CAPA's management systems
26. Performs shop floor walk through audits and challenge adherence with area procedures, coaching and Quality Support in alignment to the business unit to optimize compliance and efficacy.
27. Verifies consistency with other site procedures and/or specifications.
28. Reviews and approves investigations related to process, products, utilities, microbiology laboratory and calibrations.
29. Approves Corrective and Preventive actions (CAPA's) and prepares CAPA Effectiveness report.
30. Evaluates and approve critical area drawings.
31. Serves as a liaison with internal and external customers.
32. Owns expiry date master procedure.
33. Approves or reject specifications impacting drug products, raw material or packaging components.
34. Ensures the designation and monitoring of storage conditions for quarantine materials and products.
35. Ensures that an effective system for returns and salvages that include assessment, investigation and disposition is in place.
36. Prepares site Key Performance and trending metrics.
37. Participates in the Material Review Board.

Knowledge/Skill:

• BS in Natural Science (Chemistry, Pharmacy, Microbiology, Biology, Engineering or a related pharmaceutical science) withfive (5) years of progressive managerial experience within the quality assurance function of the pharmaceutical/health care industry and regulatory agencies, and 5 years of experience in one of the following areas: aseptic filling and finishing for liquid and lyophilized products, oral solid dosage and medical devices; or

Master Degree or PhD in Sciences or Engineering with three (3) years of experience in a quality function within a pharmaceutical / health care industry, with two (2) years of direct / indirect supervisory or managerial experience and experience in one of the following areas: aseptic filling and finishing for liquid and lyophilized products, oral solid dosage and medical devices.

• Ability to develop and apply BMS's operating philosophy and to operate within Company policies and procedures within Manufacturing, Quality and Compliance, Marketing and Regulatory areas.
• Proficient in cGMP's and FDA / EMA regulations and requirements.
• Experience in containment technologies.
• Understanding of the business and marketing aspects of pharmaceutical operations in a highly regulated industry is extremely important for evaluating the potential impact of product decisions.
• Excellent verbal, written and presentation skills.
• Must be innovative and creative and utilize all available resources.
• Working knowledge in PC's and electronic tools.
• Excellent communication skills in both English and Spanish.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.